Exploring the CADIFA Handbook: Guidelines for Administrative Procedures

The CADIFA (Active Pharmaceutical Ingredient Dossier Adequacy Letter) is an administrative instrument that attests to the compliance of the DIFA (Active Pharmaceutical Ingredient Dossier) with the requirements of RDC Resolution No. 359/2020. It guarantees the quality of the API according to some specified tests.

The cadifa is a necessary document for the registration of an IFA, for all companies that want to sell pharmaceutical products in Brazil. To begin with, the company must have a base in Brazil, whether it is a Holder or a subsidiary, in addition, two responsible persons who must be the security manager, for the use and submission of information from the Anvisa system in the requested system.

We will talk about the guidelines on the structure and content of DIFA, along with information on the electronic petition and the procedures for communicating with Anvisa.

Before submission:

Anvisa recommends one DIFA holder per company or business group, representing all manufacturing sites. The security manager is responsible for accessing and managing the information in Solicita on behalf of the DIFA holder.

The registration of the security manager is different from that of the regulatory user, being an important point of attention. Updating the security manager’s information is crucial, and the registration procedure should be carried out only once for each DIFA holder and security manager.

Types of petition

There are different types of petitions that can be made in relation to CADIFA, from the initial request to changes and responses to requirements. Let’s get to the main points:

Types of Initial Petitions:

   – Associated CADIFA Application: For use in drug registration or post-registration application.

   – Expression of Interest: When the CADIFA holder wants to obtain a CADIFA, but there is no associated drug registration demand.

   – Non-Associated CADIFA Request: Requested by Anvisa after the Expression of Interest or public invitation from the Collegiate Board.

CADIFA Similarity: The CADIFA holder may request another CADIFA for the same active pharmaceutical ingredient (API), following certain similarity conditions.

Petition for Change: Upon granting the CADIFA, the holder must submit a Petition for Change to update information, following the available change codes.

Compliance with Requirement: Response to the Notice of Requirement issued by Anvisa, requesting information or clarifications.

Other Petitions: Include amendment, withdrawal, suspension, cancellation, rectification and appeal.

These petitions have specific deadlines and procedures that must be followed to the letter.

The organization of the Information Document for the Registration of Active Pharmaceutical Ingredients (DIFA) according to the guidelines established by Anvisa, are:

DIFA Organization: The document is divided into three modules: Administrative Information, Summary of Common Technical Documents and Quality. Module 2 is optional for electronic submission.

File Requirements: Files must be submitted in PDF format, allowing textual search and copying, with a maximum size of 25MB. It is recommended to avoid scanning whenever possible.

Naming Files: It is recommended to follow a specific pattern for naming the files, including the section, document type, and, if necessary, additional information for differentiation.

Module 1: Administrative Information: This module contains mandatory administrative documents such as petition forms, responses to technical requirements, meeting minutes, and other relevant information.

Module 2: General Quality Summary: Optionally, this module may contain a summary of the quality of the active pharmaceutical ingredient.

Module 3: Quality: This module includes documents related to the quality of the active pharmaceutical ingredient, such as general information, manufacturing, quality control, stability, and others.

Division of Quality Documentation: In cases of confidentiality, quality documentation should be divided into part open and part restricted.

Reference to Studies: It is possible to reference non-clinical and clinical studies presented in the drug registration application or to submit qualifying studies in the impurities section of DIFA.

Submission of the petition

Step by Step for Submission of Petition in the Solicita System:

 Initiation of the Petition:

   – The petition with Electronic Protocol must follow the instructions in the User Manual.

   – The process will be started and completed in Solicita, with the documentation sent by the system and the issuance of a voucher.

. Solicita Home Screen:

   – After logging in, the Solicita home screen will appear, containing two main sections: the sidebar and the results section.

   – In the sidebar, you can select the desired functionalities for the petition, such as draft, payment, voice mail, etc.

   – In the results section, the documents will be presented according to the chosen functionality.

Drafts:

   – If there are no new messages in voicemail, the drafts screen will be displayed after logging in.

Document Checklist:

   – Each petition has a specific checklist with the required documents.

   – In the electronic protocol, it is mandatory to attach at least one file for each checklist item.

   – If a document is optional or does not apply, attach a file justifying its absence.

Rescue of the Petition:

   – After selecting the subject, it is possible to save the petition for later submission to Anvisa.

   – Saved and unsubmitted petitions will be available in the drafts section.

Proof of Filing:

   – After any petition with electronic protocol, a receipt will be issued containing information about the petition, the security manager and the DIFA holder.

   – The reference number (process number) must be informed to the drug applicant/holder for use in drug registration or post-registration.

Follow these steps to ensure efficient and proper submission in the request system for CADIFA-related petitions.

Communication with Anvisa:

   – The P.O. Box is where Anvisa’s messages are received. Go to read notifications, such as approvals or requirements.

After subimission

Accompaniment:

   – Check the status of the petition in the Document Status Enquiry system by registering an email to receive automatic notifications on the status of the application. After submission, Anvisa will assess compliance with Resolution – RDC No. 359/2020.

Possible Outcomes:

   – Deferral: CADIFA granted or revised, or sending a Letter of Deferral.

   – Requirement: Notification of requirement requesting more information.

   – Rejection: Petition rejected due to lack of documentation or failure to meet requirements.

These are just some guidelines on how this process works, if you need regulatory support from a specialized consultancy, count on Kivalita Consulting, talk to us today!

NORMATIVE INSTRUCTION – IN N° 290 of RDC 741 of August 2022

It deals with the procedure for the analysis and decision of petitions for registration of medical devices, with analysis by international equivalence

Published on 04/08/2024, the new IN brings a possibility of primary registration, without the need to redo analyses already approved by international bodies. For the purpose of adopting the optimized analysis procedure, the following AREE and respective proof of registration or authorization are considered:

I – Austrália: Australia Therapeutic Goods Administration (TGA) – Australian Register of Therapeutic Goods (ARTG);

II – Canadá: Health Canada (HC) – Medical Device Licence;

III – United States of America (USA): US Food and Drug Administration (US FDA) – 510(k) Clearance, Premarket Approval (PMA) or 513(f)(2) “De Novo”; and

IV – Japão: Japan Ministry of Health, Labour and Welfare (MHLW) – Pre-market approval (Shonin).

This new IN will be effective on June 3, 2024.

Looking for guidance in brazilian legislations? contact us for a deep analysis of your demand

Regulatory framework: ANVISA publishes public legislation consultation on cosmetovigilance.

On March 26, ANVISA published the opening of a public consultation on a new RDC on cosmetovigilance (post-marketing/post-use monitoring of cosmetic products).

The municipality sees this new legislation as a regulation of what is already practiced within companies, and has opened a public consultation on which it runs until April 2, 2024.

To participate, simply access the electronic questionnaire available on Anvisa’s portal and fill in the requested information. Keep in mind that registered contributions will only be considered valid after the participant clicks on the “SUBMIT” button, available at the end of the questionnaire.

What it says?

The RDC contains 3 chapters and 1 annex, which are named as: Purpose and Scope (Chapter I), Company Cosmetovigilance System (Chapter II), Final Provisions (Chapter III). It also deals with the requirements for the implementation, organization, operation and maintenance of the Cosmetovigilance System and notifications of adverse events.

To learn more, be sure to check out our live on the subject: How to implement a cosmetovigilance plan in the cosmetic industries. follow on social midia so you don’t miss it!

ANVISA’s Guide No. 62/2023 : Risk Management for Quality Excellence

In the complexity of the production processes of the life sciences sector, risks are inevitable. In-depth understanding of these processes is critical to identifying and mitigating risks. Risk management is not only a best practice, but a regulatory requirement in critical sectors such as pharmaceuticals, cosmetics… under the surveillance of agencies such as ANVISA.

Guide No. 62/2023, a July 2023 publication, serves as a detailed manual for pharmaceutical companies to navigate the complex process of identifying, minimizing, and eliminating risks that affect the integrity and quality of products. Inspired by the ICH’s Q9(R1) guide, this document is a roadmap for effective risk management.

To better understand how risk management can add quality to the product, it is first necessary to understand some basic concepts.

Risk identification is a complex process that requires an objective and structured approach. Subjectivity can be minimized with the use of analytical tools and brainstorming sessions to map all potential risks, which will later be evaluated in the risk matrix, in this article we talk more specifically about some well-known methodologies.

Risk management is a continuous cycle of evaluation, control, communication and review, ensuring that product quality is maintained in all phases of its life cycle, in RDCs of good pharmaceutical manufacturing practices for example, the need to have risk management for each decision to be made within the process,  expresses the importance of this action for Anvisa and companies.

To understand the guide, you can consider:

2. Principles of Quality Risk Management: includes risk assessment based on scientific knowledge and the adequacy of risk management effort to the level of risk.

3. Overall Quality Risk Management Process: Details the steps to manage risks, including risk assessment, control, communication, and review.

4. Risk Management Methodology: discusses formalities in the process, risk-based decision-making, and ways to manage subjectivity.

5. Integration of Risk Management into Operations: addresses how risk management should be incorporated into industrial and regulatory operations to improve decision-making and product quality.

In addition to the appendices, where it is possible to find some methodologies for the application of risk analysis, statistical tools to support and classification and filtering of risks.

The success of risk management depends on collaboration between all areas of the company. A multidisciplinary team with decision-making authority is essential to implement and oversee the risk management process.

At kivalita, we have a methodology that employs risk management in the strategy not only of quality, but in the business strategy, learn how we can help your company and the quality sector achieve the greatest goals.

Audit vs Gap Analysis – Understand the impact of each one on your organization.

When a quality manager realizes that he needs greater control over what happens in the company’s day-to-day, he usually resorts to a self-inspection or even an external audit, to bring a less internalized view of the process, which is in fact a practice required by legislation in the Life Science sector.  But is it always the best way when it comes to the business vision?

We believe there is another way to better understand how processes work, and what improvements or adjustments can be made. Gap Analysis comes as a tool for this. The quality sector usually has a very busy day-to-day and the managers of this sector do not usually have time to move away from the processes and understand the root causes of the problems or the reflection of the deviation that starts in quality and transits throughout the area.

An audit is like a “photo” of the current scenario of the processes, visualizing only the deviations. Therefore, a Normal Audit obtains around 40 deviations and opportunities for improvement. With this, we determine that an audit is like a corrective maintenance of processes, acting only on deviations and investigating them. Just like corrective maintenance of a vehicle, changing only the parts that caused the problems.

Gap Analysis works as a critical study of processes, evaluating procedures, regulatory documents such as licenses, operational flows, and interviewing professionals in the areas. With this, we were able to map the entire process and detect the GAPs with regulatory and business strategy impact.

Therefore, a GAP Analysis finds an average of 250 to 400 GAPs per plant which are placed in risk analysis to be treated according to their criticality in the short, medium, and long term.

With this, we determined that a GAP Analysis is like preventive maintenance, predicting the GAPs about the process before the problem happens.

Today, quality needs to overcome the barrier of “sector” and start to see the quality system as something systemic, and the Gap Analysis will help those who are in this phase. In addition, it supports managers who want to transform their team and processes to embrace plans that are usually neglected, of continuous improvement and out-of-time adjustments.

This product is an exclusive Kivalita method and can support any type of project that your company is implementing, which can be: ISO certifications, regulatory adaptation projects, validations and qualifications, laboratory projects and more. Count on our professionals  and let’s talk about your demand and how Gap Analysis can help.

All about the new API Guide No. 71/2024 in Brazil

Anvisa’s guide No. 71/2024, which deals with the continuous production of APIs (active pharmaceutical ingredients), has just been released on January 11, 2024, bringing many relevant scientific and regulatory aspects for those who want to sell inputs in Brazil, taking into account good management and development of the production life cycle.

In recent years, after the health crisis generated by Covid-19 that promoted a great movement in the market, with the exhaustion of APIs previously exported from countries such as China and India, Brazil has experienced a significant growth in the number of domestic suppliers. The Ministry of Health “expects to produce 70% of the demand for various health products in Brazil in 10 years” and brings a good outlook for the year 2024, as disclosed at the Active Pharmaceutical Ingredients seminar held by ABIFIQUI (Brazilian Association of the Pharmaceutical Ingredients Industry) in December 2023.

The guide launched on the 11th applies to chemical entities and therapeutic proteins, in addition to covering new products, and biological and biotechnological entities.

The document provides the following definition: “Continuous Production involves the continuous feeding of input materials, the continuous transformation of materials in processing, and the concomitant removal of processed materials from the manufacturing process.

The guide provided is based on some ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) guides, starting from the Q7 guide, on Good Manufacturing Practices for APIs, to Q12, which brings regulatory considerations for the management of the life cycle of pharmaceutical products. The ICH, according to ANVISA, “…is the world’s leading forum for the harmonization of technical requirements, composed of regulatory authorities and the pharmaceutical industry.” The main topics covered in Guide No. 71/2024 are:

  1. Control State
  2. Process dynamics
  3. Materials characterization and control
  4. Equipment design and system integration
  5. Process monitoring and control
  6. Traceability and segregation of materials
  7. Process Modeling

Continuous improvement

When discussing some scientific approaches, Guide 71/2024 talks about how Continuous Production provides the application of the philosophies of Continuous Improvement, called here as Control Strategy. According to this philosophy, a holistic approach to CP, ICH guidelines, risk management principles and some current legislation, favors the development of a Control Strategy. For this, it is necessary to consider aspects such as:

  1. Input Material Attributes
  2. Process monitoring and control
  3. System Operation
  4. Segregation and collection of materials
  5. RTRT
  6. Integration of equipment and systems

All these attributes need to be detailed and documented in the continuous production dossiers, in order to ensure the control of the product produced and thus enable the application of performance indicators.

The Guide to Continuous Production of Active Pharmaceutical Ingredients is a document with mostly technical language, with broad definitions of how the API production system should be and how to document it. Examples of dossiers and technical diagrams can be found in the annexes. It is important to emphasize that this is not a normative document, but a guideline one, and it is up to the companies to choose whether or not to follow the instructions described therein, provided that the implications in the current health regulations are observed.

Kivalita Consulting has extremely qualified professionals, with the necessary expertise to help your company achieve this regulatory compliance, with a team specialized in the pharmaceutical sector, ensuring autonomy and speed. Talk to us today about your demands!

Quality tools for strategic decision making

Strategic decisions play a vital role in the success of any organization. The ability to identify, evaluate, and select the best options to achieve long-term goals is critical. In this context, quality tools, widely used in quality assurance and control sectors, stand out as valuable resources that inform and improve strategic decision-making processes, not only within the quality sector, but also in decisions at administrative levels.  In this article, we’ll explore how to use these tools effectively.

Introduction to quality tools

Quality tools are a set of techniques and methods that help organizations understand and improve their processes, products, and services. While these tools were originally developed to ensure quality in the industry, they have proven to be highly adaptable and beneficial in a variety of industries, including strategic decision-making.

The role of quality tools in decision-making

1. SWOT analysis (strengths, weaknesses, opportunities and threats)

SWOT analysis is a well-known tool used to assess an organization’s position in its environment. Helps identify internal strengths and weaknesses, as well as external opportunities and threats. Based on this analysis, strategic decisions can be guided to exploit strengths, reduce weaknesses, exploit opportunities, and respond to threats.

2. Priority matrix (GUT matrix)

The priority matrix is a simple but effective tool that ranks options based on specific criteria such as severity, urgency, and trend. This helps organizations decide which actions to prioritize by providing an objective framework for strategic decision-making.

3. Root cause analysis

Root cause analysis is an important tool for understanding underlying issues that can impact an organization’s strategy. Identifying the root causes of a problem allows strategic decisions to be directed toward addressing those causes, rather than just dealing with the symptoms.

4. PDCA

The PDCA cycle, which stands for “Plan-Do-Check-Act” (or “Plan-Do-Check-Act” in Portuguese), is a method of continuous improvement widely used in various departments and environments. It operates as a cyclical, iterative process designed to continuously improve the efficiency and effectiveness of a process, product, or service.

Planejamento (plan): Nesta fase, a organização identifica o problema, define metas e objetivos claros e desenvolve um plano de ação detalhado para atingir essas metas. O planeamento também inclui a identificação dos recursos necessários e a antecipação de potenciais obstáculos.

Do (do): Here is executed the plan developed during the planning phase. Perform actions as planned and record all activities for future analysis.

Check: During the validation phase, the results are monitored and compared with the goals established in the planning phase. This involves collecting and analyzing data to determine if goals are being met and if the plan is working as expected.

Act: Based on the findings of the verification phase, corrective actions are taken. If the results are in accordance with the goals, the improvements are consolidated and the processes are standardized. If there are deviations, root causes are identified and corrective measures are implemented to adjust the original plan.

Following the general market trend of systematic, data-driven approach to evaluating options, identifying problems, and prioritizing actions, the tools in the strategic decision-making process can better adapt to changes in the business environment and increase your chances of long-term success.

Therefore, investing time and resources in understanding and applying these tools can be a sensible strategy for any organization looking to improve its strategic decision-making. Count on the personalized training of Kivalita Consulting to take more of this practice into your business, learn more.

Internal vs. External Audits: Advantages and Challenges at Self-Inspection

In the modern business landscape, where quality, compliance and efficiency are essential, conducting audits is a crucial practice. Audits, in their variety of forms, play a key role in evaluating and improving an organization’s processes and systems.

Among the options available, internal and external audits stand out, each with its own unique advantages and challenges. In this article, we’ll explore the differences between these two types of audits and how self-inspection can be a strategic tool for success.

Internal Audits: Looking Inward with Strategic Focus

Internal audits are performed by the organization’s own team, usually by the quality department or compliance team. This approach has several advantages. First, internal auditors have an in-depth knowledge of the company’s internal processes and culture, allowing for a more contextualized analysis. In addition, conducting frequent internal audits promotes a culture of self-assessment and continuous improvement. The internal team is also more accessible for collaboration and process adjustments if needed.

However, internal audits can face challenges. The fact that auditors belong to the same organization can create conflicts of interest or concerns about the objectivity of the results. In addition, familiarity with the daily routine can lead to a partial view, not identifying issues that an outside observer might notice. Therefore, maintaining a balance between objective analysis and internal knowledge is key.

External Audits: An Unbiased and Comprehensive Perspective

External audits, conducted by independent third parties, bring a degree of objectivity that can be difficult to achieve internally. External experts bring diverse experience and knowledge of industry best practices. They see the organization from the outside in, identifying gaps that may go unnoticed by internal teams. This can be particularly valuable in ensuring that operations comply with external regulations and industry standards.

However, external audits also have their limitations. The lack of internal knowledge can result in generic solutions that may not be feasible for the organization, but that with the support of the internal team, can be easily circumvented. 

Além disso, o custo financeiro e logístico de trazer uma equipe externa pode ser significativo, se a empresa for de difícil acesso, por isso, uma alternativa, é contratar consultorias que are closer to the company geographically, or consider looking for the best cost-benefit in the market.

Strategic Self-Inspection: The Advantage of Self-Reflection

In a world where both internal and external audits have their advantages and limitations, self-inspection, or self-assessment, can be a strategic component. It involves the careful analysis of processes and systems by the organization’s own team. This allows you to identify strengths and weaknesses on an ongoing basis, adjusting procedures as needed. Self-inspection also prepares staff for external audits, minimizing surprises.

However, self-inspection also has to deal with challenges. The internal team can cling to biases and lack of objectivity, and it can be difficult to identify problems when immersed in the routine. Therefore, successful self-inspection requires a balanced approach, involving internal critical review and, when necessary, seeking the expertise of third parties.

This self-inspection can be done not only in one sector, but also in several sectors to ensure that gaps are being traced from their origin.

To ensure a comprehensive gap correction plan in your company, get to know Kivalita Consulting’s Gap Analysis.

Choosing the Best Approach

Internal and external audits play crucial roles in maintaining an organization’s quality, compliance, and efficiency. When choosing between the two approaches, it is important to consider the specific characteristics of the company, its culture and goals. Self-inspection, in turn, is a strategic tool that should not be underestimated. The right combination of these methods can ensure that the organization is always on track for sustainable success.

Regardless of the approach chosen, conducting audits is an indispensable practice for any organization committed to excellence, compliance and continuous improvement. The search for the balance between internal self-assessment and external evaluation will contribute to the constant evolution of the company in today’s competitive and regulatory scenario.

To carry out audits, count on Kivalita, we have professionals specialized in the most demanding legislations in the market, and always updated.

Shelf life of cosmetic products requires attention

Estimar a “shelf-life” (ou “vida útil”) de um produto é muito importante para o sucesso do negócio. Como em qualquer setor, em especial o de cosmético, é fundamental considerar as projeções sobre os custos operacionais de fabricação, ambiente de armazenagem, distribuição e vendas dos produtos no planejamento da empresa. 

Mais do que isso, também é preciso estar atento às validações de cada uma das etapas incluídas nesses processos, visando estender a shelf-life dos produtos cosméticos e garantir que, ao final, eles serão entregues ao mercado com a qualidade que o consumidor requer.

Fatores que podem impactar na vida útil

Muitos são os fatores que podem impactar a shelf life de um produto cosmético. O próprio ambiente de armazenagem pode alterar a sua composição, por exemplo. Dependendo do cosmético, a cor e a textura podem mudar ao serem expostos à luz solar ou mesmo apenas ao ar. Portanto, é preciso verificar as condições de armazenagem dos produtos cosméticos, de modo que estejam nas condições ideais para sua preservação, como estocá-los em ambientes mais frescos e longe da luz solar direta.

O prazo de validade também pode ser um desafio, pois está diretamente ligado à escolha do tipo de embalagem. Um tempo curto de validade pode requerer recipientes menores e necessidade de refrigeração do produto, enquanto a flexibilidade é maior para os produtos com prazo longo de validade.

O fabricante também precisa ser transparente ao compartilhar as informações sobre a shelf-life de um produto cosmético com os seus consumidores. O fato é que o cliente precisa saber todas as condições que deverá adotar para manter o produto preservado, buscando estender sua vida útil após adquiri-lo. Caso contrário, a insatisfação dos clientes pode acarretar grandes perdas à marca.

Outro fator a ser considerado é a ameaça de crescimento de fungos e bactérias, que podem ocorrer até mesmo no estágio de produção do produto. Por isso, os responsáveis pela área de produção devem certificar que todos os recursos, equipamentos, processos e pessoas sigam boas práticas para assegurar a entrega de produtos cosméticos com qualidade.  

Teste de estabilidade como boa prática de qualidade

Globalmente, os testes de estabilidade de rotina estão na lista de boas práticas de fabricação de produtos cosméticos e podem fornecer dados valiosos aos seus fabricantes, tanto sobre a segurança quanto a vida útil de seus produtos. São informações muito úteis, em termos de insights para a gestão de produtos, em especial para expandir sua “shelf-life”.

De olho da identificação de falhas e na gestão da qualidade

É fundamental que os fabricantes mapeiem e identifiquem possíveis falhas nos processos inerentes à shelf-life de produtos cosméticos. Nós da Kivalita Consulting, somos especializados no desenvolvimento da gestão de qualidade de processos e validação de tecnologias para empresas da área de Life Science, o que inclui as de cosméticos.

Aqui, apoiamos nossos clientes com a metodologia “Gap Analysis“, sendo aplicada como uma ferramenta de qualidade para o mapeamento de processos na organização, além de ser uma boa estratégia para diagnosticar falhas e oportunidades de melhorias. 

É justamente através desse método que a empresa passa a ter conhecimento e uma visão sistêmica, com uma perspectiva sobre o negócio que não se tinha até então. Mais do que isso, torna possível criar uma capacidade de avaliação crítica e não despartamentalizada para trabalhar melhorias a cada falha revelada. Traz ainda aos gestores, oportunidades de tomar decisões mais assertivas. 

O contrário, ou seja, a má gestão da qualidade nas organizações, pode trazer prejuízos e a queda de indicadores de performance. Processos com qualidade ruim elevam os custos, geram desperdícios e retrabalhos. Exemplos de Gaps mais comuns nas organizações de Life Science, que podem impactar a shelf-life de produtos cosméticos são:

Você sabia que dependendo do tamanho da organização, esses apontamentos de “Gap Analysis” serão maiores e mais complexos, visto que o número de processos mapeados também será proporcionalmente maior. Para se ter uma ideia, nas pequenas organizações de Life Science, essa lista pode chegar até 300 gaps, em média, por planta fabril.

Que tal falar com os nossos especialistas e saber como podemos ajudar a sua empresa a identificar, e solucionar eventuais falhas nos processos que podem ameaçar diretamente a shelf-life de produtos cosméticos?

Entre em contato! Será um prazer falarmos a respeito!

How to have an ISO certification without making the adequacy painful

The dream of many companies when it comes to process excellence, ends up obtaining an NBR/ISO 9001 certification, but the process for this goal can be quite painful, especially if the current status of the company does not meet the minimum that the legislation requires. To help in this process, here are some steps to be taken so that the adequacy occurs in a gradual and efficient way.

1. Make the decision together with the leaders

The decision to have an ISO 9001 certification is not individual and does not depend only on a part of the company. It needs the support of all the teams involved, from implementation to final adjustments to achieve the seal. Therefore, when the time is right, the ideal is to bring together the company’s leaders to verify that certification should actually be the company’s goal.

2. Predict project costs

Besides not being an individual project, it is also not usually cheap. Having well planned costs, predicting unforeseen and the manpower needed to implement the actions is of paramount importance. Keep in mind that the investment is proportional:

3. Train not just the implementation team but everyone involved

Having a team involved in the project, will make the process much less time consuming and painful, because if there is resistance from employees, the schedules always end up delaying. For this does not occur, periodic training, presenting the advantages of having a certification is indispensable, because everyone needs to have the vision of improvement of the organization and not only management.

4. Having a third-party implementation team can make it easier

The team involved in the actions of improvement and modifications of irregular routines, cannot have vices or personal relationships with workers or employees, so that it has coldness in the time to correct or change something, and clarity in the time to guide the staff.

There are many certifications that a business can aim for, but having these points in mind can result:

It no longer needs to be a dream, it is possible to have your ISSO 9001 certification, just rely on available technology, specialized people, and organization at the time of planning. Here at Kivalita, we specialize in Certifications for pharmaceutical, cosmetic, veterinary, sanitarian, homeopathic and other companies, and we are ready to assist your company, but if you still have questions about whether an ISO certification is worth it, click here and find out now!

Quality management: validation of cleaning and processes in a strategic way in the manufacture of pharmaceutical products

By Bárbara Guelfi (founder and CEO of Kivalita Consulting)

For any industry, production lines include numerous factors for which managers should be aware. Especially with regard to quality management, it is vital to ensure the manufacture and delivery of products accordingly not only in relation to the standards established by the company itself, but especially with regard to the Good Manufacturing Practices (BPFs) required by the market.

For the pharmaceutical sector, specifically, there are several requirements of BPFs and, among them are validations for the production lines, be what we call “process validation” – which is the evaluation of yield, production standardization, etc . – and “cleaning validation” – which is the pointing, prevention and action on residues and contaminants on the production line.

Thus, the difference between them is that process validation standardizes and defines the criteria (yield and productivity, among others); while cleaning validation ensures that these processes have no residues (such as detergents and products), or microbiological contamination in manufacturing.

The criteria for these validations can be defined from a “pre-study” by the manufacturer and related to a computerized system, used in production lines. Both validations are challenging, and it is the responsibility of all those involved – and not just quality specialists – to be aware of the points that must be improved in the production lines. 

If the company has more than one product manufactured on the same production line, in the pharmaceutical area it is necessary to validate each of them individually. In other areas of the market, a process called “worst case” (or, in the Portuguese: “the worst case”), is carried out in which the product to be validated to represent the others must be the one that most challenges the manufacturing process in terms of toxicity, yield, etc.  And in the case of “worst case” for cleaning, viscosity, solubility, etc. are considered.

For all validations it is critical that they are repeatable, reproducible and robust (RRRs). Although we speak here specifically for the pharmaceutical industry, these criteria are also applicable to other areas of Life Sciences:

However, it is true that to perform them it is necessary competence, as well as for the definition of validation criteria in a way that does not impact the productive performance or day-to-day performance of operational teams. Therefore, developing a good strategy aligned with the business objectives is essential.

Moreover, if we talk about cosmetic products, for example, most do not have compendiais methods for reference in the elaboration of such criteria, and each of them has its own specificity in particular – which is a challenge when performing validations, hence the need for qualified and competent professionals in the issue.

Specialized Manpower

A good strategy not to impact the business and, at the same time, have high competence in process validation or cleaning validation is not to make use of the time of internal teams, to perform such validations, because the company’s employees are already compromewith their daily tasks – and, this can impact the work routine as a whole.

We at Kivalita Consulting, as a Brazilian consultancy specialized in the development of quality management and technology validation for companies in the area of Life Sciences, offer professionals specialized in the area of process analysis and validation, and cleaning for the pharmaceutical industry.

Talk to us and learn more about applying the outsourced hiring modality – from assistants to managers, with exclusive and proprietary periodic supervision and training – so that your teams can stay focused on business-critical activities, while our professionals take care of the validations necessary to keep their production lines compliant and with operational excellence!

Understand how poorly plans can cost millions

Um gestor da qualidade tem responsabilidade de fazer o planejamento das demandas que o setor da qualidade que precisam de revisão ou obtenção de novas licenças e outras burocracias, porém um planejamento mal-feito pode criar um efeito dominó de consequências negativas. 

As qualificações e validações são uma garantia que os equipamentos e processos como o de limpeza vão atender as normas mínimas exigidas pela Anvisa, a fim de garantir a segurança de pacientes e integridade do produto, quando as renovações anuais não são feitas podem gerar problemas como: 

Caso um apontamento do ano anterior não seja corrigido por negligência de um planejamento, a Anvisa pode aplicar multas de até 75 mil reais, por cada gap reincidente ou até mesmo, proibir a comercialização de produtos, causando prejuízos milionários para a corporação. 

Para evitar esse tipo de problema, o ideal é corrigir gaps antes das auditorias anuais obrigatórias, e promover uma auditoria interna, gerando um relatório pré-inspeção e assim entender onde estão os problemas da sua organização. 

Uma análise minuciosa no setor de qualidade já é uma prática comum em auditorias, mas já imaginou ir além e ter um apoio contínuo para que o planejamento seja sempre atualizado com relação as demandas e mudanças da empresa? Conheça o Continuous K.