FDA issued over 50 warning letters in 2023 due to GMP violations which could easily be discovered with a reliable gmp audit service provider. A generic drugs maker in Europe faced a three-year import alert because of systematic failures related to data integrity observed at several of its manufacturing facilities.

These aren’t isolated incidents. Poor quality management sits behind most of them. In nearly every case, a timely GMP Audit by experts would have caught the problem first. 

Manufacturing a drug that will reach patients safely and effectively is always a goal of pharmaceutical organizations. Inability to produce pharmaceutical products in accordance with established regulatory requirements lead to numerous penalties, recalls, product safety concerns, reputation damage, and even legal liability.

Therefore, performing regular GMP audits is not something you want to postpone until regulators notify you about deficiencies. GMP audit services across provide a way to assess the performance of manufacturing operations and quality systems objectively.

Definition of GMP Audits

The best GMP audit services in India encompass the evaluation of manufacturing operations, facility environment, production and quality control documentation, as well as personal practices. The main point of such an audit is to verify compliance with GMP rules including FDA 21 CFR 210/211, EU GMP Guidelines, ICH Q10, WHO Technical Requirements, among others.

By performing GMP audits, organizations ensure that all products are produced in adherence with procedures and instructions established by regulatory bodies.

Auditing of manufacturing operations does not end with checking if there are any inconsistencies between practices and regulatory documents. Audits allow assessing current quality management practices against expectations of regulatory authorities and identifying opportunities for improvement missed by internal teams.

Why Are GMP Audits by Professional GMP Audit Service Providers Becoming More Important?

There is a lot going on in the field of regulatory inspections nowadays, making GMP audits very important to conduct on regular basis.

  • Growing number of regulatory consequences: During the last decade, FDA, EMA, and WHO intensified their inspection programs and increased the number of enforcement actions. Unannounced inspections are becoming more and more popular in EU countries. Import alerts issued by FDA make certain products unavailable on the US market for extended period of time. Warning letters issued by any regulator may lead to requirement for companies to conduct audits of their manufacturing operations to address deficiencies revealed.
  • Increasing supply chain risks: With the globalization of the pharmaceutical industry, pharmaceutical supply chains become more complicated every year involving multiple suppliers, CMOs, laboratories, etc. Under ICH Q10 or similar regulations, organizations become liable for all activities outsourced by them even if they take place in other countries. One non-compliant supplier of APIs, packaging materials, etc., may affect the whole supply chain and cause significant problems.
  • Risk of data integrity issues: Over the recent years, cases of data integrity violations have become widespread all over the world. Some of the examples of non-conformities reported by regulatory bodies included backdating batch documentation, falsification of out-of specification test results, manipulating audit trails, etc. At present, GMP audits always encompass a special evaluation of data integrity controls.

Common Types of GMP Audits

  • Internal audits or self-inspections: The main objective of internal audits of manufacturing operations is to evaluate quality management processes within organizations. The absence of such audits or their ineffective organization is often considered as one of the signs of poor quality management practices by regulators.
  • Supplier qualification audits: The qualification of potential new suppliers is essential to verify that all activities performed on behalf of companies comply with GMP requirements. Not qualifying your suppliers and conducting periodic requalification can expose you to risks of quality deviations or regulatory sanctions.
  • Suppliers re-audits: Even qualified suppliers need to undergo regular audits of their manufacturing operations. Personal changes, gradual drift from existing procedures, equipment wear, and other factors can cause suppliers of pharmaceutical ingredients to become non-compliant with regulatory expectations.
  • Inspection readiness audits: Inspection readiness audits help to prepare for upcoming inspections of manufacturing operations conducted by regulatory bodies and simulate conditions when FDA or EMA Audit inspectors inspect operations. The best way to pass inspections without significant problems is to prepare for them.
  • Gap assessments: Gap assessments allow comparing existing manufacturing and quality control practices with GMP requirements to evaluate the gaps. Such an assessment is especially helpful in case of entering a new market or launching products into a new category, etc.
  • For-cause audits: For-cause audit are needed in case of serious concerns such as deviations, complaint trends, or frequent out-of specification results. This type of audits helps to understand why some things happened and if the existing preventive measures are adequate to prevent future incidents.

Advantages of Third-Party GMP Auditors

Auditors working for organizations themselves are valuable employees, yet they have certain disadvantages as they know your operations well and, thus, can overlook many issues. An auditor who is familiar with GMP in all aspects, performs audits on a regular basis, knows your supply chain, and sees everything with the eyes of an expert may find more problems.

While choosing a provider of GMP audit services, it is important to pay attention to some criteria which include:

  • Knowledge of GMP
  • Industry experience
  • Risk-based audit approach
  • Reporting and recommendation structure
  • Complete independence from the outcome of audit

Additionally, it is worth considering a confidentiality agreement with auditors, possibilities to provide assistance in implementing corrections made, and previous experiences relevant to your type of products and geography.

Preparation for Inspections

Preparing for regulatory inspections does not mean doing certain activities prior to FDA or EMA visits. This means keeping your quality management system in optimal condition. Organizations that are preparing for inspections on continuous basis usually report less problems and issues during inspections and, consequently, have fewer commitments and actions to implement after inspections.

Do not wait for your problems to be found by regulatory inspectors – discover them yourself!

  • Tailored to your manufacturing operations and type of regulated products
  • Thorough investigation of each issue with prioritized recommendations
  • Detailed post-audit support to ensure corrective actions are adequate
  • Long-term collaboration to improve your GMP practices continuously

To ensure that products are manufactured in compliance with GMP, you need to audit regularly. It helps you discover risks associated with current practices, mitigate them, reduce the likelihood of product defects and regulatory issues, and maintain quality and compliance management at a high level.

Considering all current trends in GMP, conducting reliable GMP audits in Indian markets becomes extremely important.