An FDA warning letter is an official message from the United States Food and Drug Administration (FDA) to a manufacturer or other organization that has violated some rule in a federally regulated activity

Newly posted FDA warning letter issued to a foreign drugmaker offers a few important lessons around trending CGMP problems that regularly appear in Form 483s and warning letters

Let’s quickly break down the deficiencies observed;
1. Failure to Follow and Document Laboratory Controls

The firm did not ensure the integrity of data generated by its Quality Control (QC) microbiology laboratory. Specifically, microbiological plates supporting API production were not read and recorded contemporaneously.

Conflicting information was provided regarding whether results had been recorded following established procedures. An investigation confirmed that test results were not documented contemporaneously, with QC personnel admitting to relying on memory for results. This raises concerns about the validity and integrity of the laboratory testing records.

The FDA deemed the firm’s response inadequate because it failed to detail a retrospective review of all documentation practices and data records for APIs distributed to the U.S. market. The FDA requested a complete assessment of documentation systems, a comprehensive investigation into data inaccuracies, a current risk assessment of the potential effects on drug quality, and a management strategy that includes a global CAPA plan

2. Failure of the Quality Unit to Exercise Responsibility

The firm’s QU failed to ensure that API manufacturing operations complied with CGMP. This included failures in confirming deviations in testing methods were investigated and resolved, ensuring adequate document control, and extending product quality complaint investigations.

The firms’ response acknowledged these deficiencies but was considered inadequate due to a lack of a sufficient retrospective review of investigations and data retention deficiencies.

The FDA requested a comprehensive assessment and remediation plan to ensure the QU functions effectively, including provisions for QU oversight, a complete review of each batch before disposition decisions, and top management support for quality assurance

3. General Observations

The FDA highlighted the inadequacy of the firm’s quality systems and recommended consulting the FDA’s guidance document on Quality Systems Approach to Pharmaceutical CGMP Regulations for implementing appropriate quality systems and risk management approaches.

The FDA also referred to the ICH Q7 guidance document for CGMP conformance in API manufacturing and the guidance document on Data Integrity and Compliance with Drug CGMP for establishing CGMP-compliant data integrity practices.

The firm committed to suspending the production of the specific API for the U.S. market and was advised to notify the FDA before resuming any manufacturing operations to ensure compliance with CGMP. The firm was recommended to engage a qualified consultant to assist in meeting CGMP requirements, with the clarification that using a consultant does not relieve the firm of its obligations to comply with CGMP

A few questions to ask in light of this warning letter:

• Have you implemented a strict policy ensuring all laboratory activities and data are documented at the time of performance, including readings, calculations, and observations?
• Are you using a data capture system to automatically timestamp actions and reduce reliance on manual record-keeping?
• Do you conduct regular training for all personnel on data integrity principles, emphasizing the importance of accurate, timely, and truthful recording of all data?
• Have you installed and enforced the use of access controls and audit trails on all electronic systems used in manufacturing and testing to monitor and protect data integrity?
• Have you developed a clear organizational structure that supports the independence of the QU, including direct access to top management for escalating issues?
• Do your investigations extend beyond the immediate batch or process to assess potential systemic impacts and proactively identify and mitigate similar issues across operations?
• Are you conducting regular internal audits to assess compliance with CGMP and identify areas for improvement?

Talk to us about auditing and remediation support if you don’t know or aren’t satisfied with your answers to any of these questions (and want to stay out of these warning letter reports).

Our quality and compliance specialists have extensive knowledge and experience in relevant regulations, guidances, and best practices related to quality system management throughout the regulated life science industries

FWQRC expert team help you by reviewing, preparing, and advising your company so you definitely pass the inspection

If you have any specific requirements or need further details, please contact info@fwqrc.com, +91 9489358902

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Overview:

Current good manufacturing practices are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices.

These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use.

The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user.

Additional principle include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase.

GMP is typically ensured through the effective use of a quality management system.

Key elements to consider:

When conducting a #⃣GMP (Good Manufacturing Practice) #⃣audit for #⃣sterile processing, it’s essential to ensure #⃣compliance with #⃣quality standards. Here are some key elements to consider in your audit checklist:
Inspection Type
Senior Personnel Summary
Facility Details
Batch Production Records
Labeling and Packaging Controls
Handling of Returned Products and Complaints

Frequency for conducting GMP Audit:

The frequency of conducting a sterile processing audit depends on several factors, including regulatory requirements, industry standards, and the specific context of your facility. Here are some general guidelines

• Regulatory Requirements
• Risk Assessment
• Internal Policies and Quality Management System
• Historical Performance
• Changes and New Implementations
• Continuous Improvement

In summary, aim for a balance between compliance, risk management, and operational efficiency. Regular audits help maintain quality and prevent deviations in sterile processing practices. Always tailor the audit schedule to your specific facility needs.

About the EUGMP License:

The #⃣EUGMP license (Good manufacturing practices) is the most important license for every drug manufacturer that wishes to sell products in the European union. This can be obtained by having an inspection from a competent authority (usually the pharmaceutical agency) of any #⃣EU member country. However, such an inspection very precise and preparing for it takes a lot of time and effort.

#⃣FWQRC expert team help you by reviewing, preparing, and advising your company so you definitely pass the #⃣inspection

If you have any specific requirements or need further details, please contact info@fwqrc.com, +91 9489358902.

#sterileprocessing #gmp #auditingservices #gapanalysis #drugs #drugapproval #drugproduct #pharma #pharmaceutical #pharmaceuticals #regulatorycomplaince #regulatoryaffairs #qualityassurance #sops #gapanalysis #riskassessment #capa #riskmitigation #riskanalysis #qualitymanagement #auditor #irca #injectables #injection #trendingpost #trendingnow #trendingnews

What is EcoVadis & How to improve your rating?

The EcoVadis score (0-100) reflects the quality of a company’s sustainability management system at the time of the assessment. EcoVadis Medals and Badges recognize eligible companies that have completed the EcoVadis assessment process and demonstrated a relatively strong management system that addresses sustainability criteria, as outlined in the EcoVadis methodology. The eligibility criteria for medals and badges are reviewed periodically.

The percentile rank of a company is calculated at the time of scorecard publication and appears at the top of the scorecard. It compares a company’s performance with all rated companies in EcoVadis database over the previous 12 months. The percentile rank is calculated across all companies in all industries, not per industry.

The EcoVadis Scorecard is valid for 12 months after the publication date. Sustainability best practices are constantly evolving, and an annual assessment provides you and your trading partners with insights into the improvements you implemented within the previous year. Expired scorecards cannot be shared with new requesting companies. After 12 months from your last assessment, new sharing requests your company receives will trigger a reassessment process.

Features & Benefits:

The benefits of registering with EcoVadis include:

Enhanced Visibility: Being part of the EcoVadis network increases your visibility among potential clients, partners, and investors who prioritize sustainability.

Benchmarking: The assessment provides a benchmark against industry peers, helping you understand your performance and identify areas for improvement.

Risk Mitigation: By addressing sustainability risks, you can reduce reputational and operational risks associated with environmental, social, and ethical issues.

Supplier Collaboration: Registration allows you to engage with your suppliers and encourage them to participate in sustainability initiatives.

Access to Reports: Registered companies receive an EcoVadis Scorecard, which provides a detailed analysis of their sustainability performance.

Remember that sustainability is not only about compliance but also about creating long-term value for your business and the planet.

Process:

To be assessed by EcoVadis, companies need to follow a simple four-step process.

1.EcoVadis Registration: Signing up through the registration page starts the process. To begin with, companies will be expected to share information about their company size, name, industry, and geography.

2.EcoVadis Questionnaire: Once the registration has been received and processed, companies will be notified, and they can begin filling out their customized questionnaire.

3.Evidence-based: the rated company must provide evidence and supporting documents and is responsible for them (strategic notes, certificates, reports).

4.Industry, location, and size matter: the assessment takes into account specific issues related to the sector, presence in risky countries, size, and geographic scope. EcoVadis has defined sustainability criteria based on international Sustainable Development standards. Among these criteria, EcoVadis selects the relevant ones for your company. This is based on your activity’s specific challenges and your geographical location.

Criteria for assessment:

The duration of the EcoVadis assessment process can vary depending on several factors. However, here are some general guidelines:

Initial Registration and Questionnaire: The first step involves registering with EcoVadis and filling out a customized questionnaire. This process typically takes a few hours to a day, depending on the complexity of your company’s operations and the availability of relevant information.

Evidence Submission: After completing the questionnaire, you’ll need to provide evidence and supporting documents. This step may take additional time, especially if you need to gather specific reports, certificates, or other documentation.

Assessment Review: Once all required information is submitted, EcoVadis assessors review your responses and evidence. The assessment team evaluates your company’s sustainability performance based on the selected criteria. The review process can take several weeks, depending on the workload and the number of companies being assessed.

Scoring and Report: After the review, you’ll receive an EcoVadis scorecard that provides a detailed assessment of your company’s sustainability practices. The scoring and report generation process typically takes a few more weeks.

Final Results: Overall, the entire assessment process—from registration to receiving the final score—can take anywhere from 4 to 8 weeks. However, this timeline may vary based on individual circumstances and the responsiveness of the company being assessed.

Pricing:

The cost of an EcoVadis assessment depends on the size of your company. Here are the annual subscription fees based on company size:

• XS (up to 25 employees): €350
• S (26-99 employees): €500
• M (100-999 employees): €1,000
• L (1000+ employees): €6,5001.

This subscription covers the EcoVadis assessment, access to the EcoVadis platform and resources, and the ability to share your company’s sustainability performance. Keep in mind that EcoVadis scorecards are valid for 12 months after publication, allowing you to access and review your results during that period.

Documentation:

Supporting documentation is a vital part of EcoVadis assessment and is critical to ensure that your company has an accurate assessment of your sustainability practices and performance.

Addressing gaps identified in your EcoVadis assessment is crucial for improving your sustainability performance.

Our expert team shall provide you the following services:

• Consultancy services to understand the scorecard and Corrective Action Plan. Supporting with implementing sustainability improvements when requested
• Independent GAP assessment by IRCA certificated Lead Auditor regarding sustainability issues and report regarding sustainability issues
• Remedial measures for the identified gaps

If you have any specific requirements or need further details, please contact info@fwqrc.com, +91 9489358902

Advanced manufacturing can integrate novel technological approaches, use established techniques in an innovative way, or apply production methods in a new domain where there are no defined best practices or experience. Advanced manufacturing can potentially be used for new or currently marketed small molecule drugs or biological products.

FDA’s Advanced Manufacturing Technologies Designation Program, which is required under section 506L of the Federal Food, Drug, and Cosmetic Act (FD&C Act), offers a framework for persons or organizations (e.g., applicants, contract manufacturers, technology developers) to request designation of a method or combination of methods of manufacturing a drug as an AMT.

Takeaway:

The program is intended to facilitate the development of drugs that are manufactured using a designated AMT, submitted in an application under section 505 of the FD&C Act (21 68 U.S.C. 355) or section 351 of the Public Health Service Act (PHS Act, 42 U.S.C. 262), and regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).

The holder of the AMT designation or another authorized party may reference or rely upon data or information about the designated AMT in an application in the same context of use for which the designation was granted.

FDA will expedite development and assessment of an application, including supplements, for drugs that are manufactured using a designated AMT as described in section 506L(d)(1) of the FD&C Act.

Use of designated AMTs can provide greater assurance of quality, shorten drug development time, assist stakeholders in more efficiently meeting regulatory requirements for commercial manufacturing, and strengthen regulatory predictability for products that use a designated AMT.

To encourage the adoption of designated AMTs, FDA offers early engagement opportunities, before application submission, with persons or organizations seeking designation of a method of manufacturing as an AMT (hereinafter requestors), designated AMT holders, and applicants to advise on designated AMTs and their implementation in drug manufacturing.

If you would like to receive notifications about regulatory guidance, email: info@fwqrc.com

Who Must Notify FDA and What Products are Subject to the Notification Requirements:

• Applicants with approved new drug applications (NDAs) or approved abbreviated new drug applications (ANDAs) for certain finished drug products.
• Applicants with approved biologics license applications (BLAs) for certain finished biological products other than blood or blood components.
• Applicants with approved BLAs for blood or blood components for transfusion that manufacture a significant percentage of the U.S. blood supply.
• Manufacturers of certain finished drug products marketed without approved NDAs or ANDAs

The notification requirement regarding discontinuances and interruptions in manufacturing of API under section 506C of the FD&C Act applies only to the manufacturers that are listed above; other entities in the supply chain for a drug, including third-party API manufacturers and suppliers, are not required to submit such notifications.

The finished products for which notifications must be submitted under section 506C of the FD&C Act are prescription drugs and biological products (including blood or blood components for transfusion) that are:

• (1) life supporting, life sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition, including any such product used in emergency medical care or during surgery or any such drug that is critical to the public health during a public health emergency declared by the Secretary under section 319 of the Public Health Service Act; and
• (2) not radiopharmaceutical drug products or any other products designated by FDA.21,22 In addition, the manufacturers listed above must submit notifications under section 506C of the FD&C Act for API of covered finished products

When To Notify FDA:

In general, manufacturers of covered finished products must submit a notification to FDA at least 6 months in advance of

• (1) a permanent discontinuance in manufacturing of a covered finished product,
• (2) an interruption in manufacturing of a covered finished product that is likely to lead to a meaningful disruption in supply of the product in the United States,
• (3) a permanent discontinuance in manufacturing of API for a covered finished product, or
• (4) an interruption in manufacturing of API for a covered finished product that is likely to lead to a meaningful disruption in supply of the API for the product

However, if 6 months’ advance notice is not possible, the notification must be submitted as soon as practicable thereafter; furthermore, a notification concerning a permanent discontinuance or interruption in manufacturing of a covered finished product must be submitted no later than 5 business days after the discontinuance or interruption in manufacturing occurs.

Failure To Notify FDA?

What is a Food Safety Plan?

A Food Safety Plan (FSP) consists of the primary documents in a preventive controls food safety system that provides a systematic approach to the identification of food safety hazards that must be controlled to prevent or minimize the likelihood of foodborne illness or injury. It contains a collection of written documents that describes activities that ensure the safety of food during manufacturing, processing, packing, and holding. See 21 CFR 117.126

Hazard analysis to identify whether there are hazards requiring a preventive control. This hazard analysis must be written, regardless of whether any hazards requiring a preventive control are identified. (Some facilities may not identify any hazards requiring a preventive control.)

When the hazard analysis identifies hazards requiring a preventive control, the FSP also includes the following written documents:

• Preventive controls (see 21 CFR 117.135), as appropriate to the facility and the food, to ensure safe food is produced, including:
  • Process controls.
  • Food allergen controls
  • Sanitation controls
  • Supply-chain controls.
  • Recall plan.
  • Other controls
• Procedures for monitoring the implementation of the preventive controls, as appropriate to the nature of the preventive control and its role in the facility’s food safety system.
• Corrective action procedures, as appropriate to the nature of the hazard and the nature of the preventive control
• Verification procedures, as appropriate to the nature of the preventive control and its role in the facility’s food safety system

If you would like to receive notifications about regulatory guidance, email: info@fwqrc.com

This guidance provides recommendations on the timing and content of amendments to tentatively approved ANDAs to facilitate submission in a timely fashion to enable final approval on the earliest date on which the ANDA may lawfully be approved based on patent and/or exclusivity protections.

The previous final version of the guidance was released in September 2020. It details the agency’s policies based on performance goals agreed with the industry under the latest Generic Drug User Fee Amendment (GDUFA III) deal.

It also discusses how the FDA plans to address ANDA sponsor requests for final approval that meet GDUFA III expectations—and clarifies the patent certification process and exclusivities and how they may affect ANDA approval times.

The timing of ANDA approval depends on, among other things, the patent and/or exclusivity protections for the RLD … An ANDA must contain an appropriate patent certification for each patent that claims the RLD or a method of using the RLD for which the ANDA applicant seeks approval in its ANDA and for which the NDA applicant is required to submit information.

If you would like to receive notifications about regulatory guidance, email: info@fwqrc.com

This ECA Guide describes and discusses the lifecycle processes for specifying, purchasing, commissioning, calibrating or verifying correct operation against instrument specifications. Configuring application and control software and ensuring continued operation of analytical instruments and systems as well as decommissioning / retirement of an instrument or system. The primary focus of this guide is for analytical instruments and systems controlling them that are operated under the pharmaceutical GMP regulations.

The Guide is divided into the following main chapters:

1. Rationale and Purpose of this Guide
2. Key Regulations, Standards and Guidance Documents
3. Brief History of AIQ and AIQSV
4. Roles and Responsibilities in AIQSV
5. Role of AIQSV in Ensuring Data Integrity
6. Analytical Instrument Qualification and System Lifecycle Process Flow
7. Risk-Based Classification of Analytical Instruments and Systems
8. System Risk Assessment
9. Why Do We Need an AIQSV Lifecycle?
10. Lifecycle Stage 1: Specification and Selection
11. Lifecycle Stage 2: Qualification/Validation of Instruments and Systems
12. Lifecycle Stage 3: Continued Performance Verification
13. How To Appendices
14. Appendix 1: Group A; Apparatus
15. Appendix 2: Group B Instruments
16. Appendix 3: Analytical Balance Grouping is Dependent on Intended Use
17. Appendix 4: Group C Systems
18. Appendix 5: Chromatography From Group B Instrument to Group C Networked System
19. Appendix 6: Group C3 NIR spectrometer for identification of raw materials using macros
20. Technical Glossary
21. References

TAKEAWAY:

This Guide is intended to provide a synopsis and discussion of current regulatory guidelines and best practices in order that a laboratory user may decide on the scientifically sound and appropriate qualification approach to ensure that analytical instruments and systems are ‘fit for intended use’ consistent with their particular Quality Management System (QMS) and compliance requirements.

If you would like to receive notifications about regulatory guidance, email: info@fwqrc.com

If you would like to receive notifications on recent regulatory guidance, please write to info@fwqrc.com