GMP Audit Checklist For API

GMP audit checklist for API manufacturers is one tool used by pharmaceutical manufacturing companies to maintain regulatory compliance. Utilizing this form will ensure all necessary information is collected for assessing adherence to quality standards and potential legal issues that may arise within their operation.

Verify whether there is an obligation under national legislation for marketing authorisation holders and manufacturers to report serious adverse reactions, and confirm there is adequate documentation in place.

1. Documentation
The GMP audit checklist for API is intended to assist in conducting a systematic inspection of facilities that manufacture drug components or finished products that adhere to Good Manufacturing Practice regulations. This inspection plays an integral role in adhering to GMP regulations.

This indicator serves to confirm that there is a system in place to oversee quality documents and records, including reviews, approval, storage and regular updates of these documents by employees. It’s essential that these systems exist so they are effective.

This indicator verifies that there is a documented system in place for receiving consumer complaints and responding quickly and thoroughly to them. Furthermore, this system must permit compliance or inspection staff accessing complaint information as part of its oversight functions.

2. Personnel
Personnel involved in performing various aspects of a GMP audit must be adequately trained and acquainted with its process in order to provide confident responses to auditors (investigators) as they conduct investigations, while also making sure all defects reported during previous audits have been remedied.

Hiring documents should outline the minimum prerequisite competencies needed by inspectors and staff involved with inspection processes. Review recruitment documents such as job announcements, curriculum vitae and resumes to ensure this is true.

An effective system should be in place to regulate quality documents. Verify that a procedure exists that outlines how to manage inspection reports and related records, including tracking their status. Furthermore, this must provide details on how designators’s authorization to assign staff for inspection is verified.

3. Processes
GMP audit checklists are essential tools for quality control and assurance professionals tasked with overseeing pharmaceutical manufacturing and inspection, as well as for inspectors or authorities conducting observations or assessments at facilities.

Check if the organization has established procedures for informing any regulated party of any findings of noncompliance with legislation, such as inspection outcome reports, investigation findings and complaints.

Verify that there is an appropriate process in place for the marketing authorisation holder and manufacturer to report any serious adverse reactions, whether through a specific reporting system or the pharmacovigilance programme. Furthermore, verify whether your organisation has in place a system for controlling documents and records such as reviewing procedures, approval processes and storage solutions.

4. Equipment
Producing pharmaceutical ingredients, finished pharmaceutical products or medical treatments requires using top-of-the-line equipment. Your equipment must be capable of handling high volumes of production while complying with rigorous pharmaceutical manufacturing regulations and protocols.

As part of your audit checklist for facilities, the facilities section requires you to assess whether your facility meets all necessary standards for pharmaceutical manufacturing: an adequate layout for pharmaceutical production; sufficient floor space; no standing water on the grounds; atmospheric controls compatible with pharmaceutical production and an effective system in place for receiving complaints and conducting investigations.

Your inspectors should have the appropriate tools and training, while all associates are aware of and comply with GMP procedures and can demonstrate understanding.

5. Packaging
GMP inspectors assess a wide array of activities and areas, such as facilities & equipment, materials, production, packaging & labeling and laboratory controls. In addition, they assess how manufacturers respond to complaints or adverse events.

Check if there is a documented system for receiving, assessing and risk classifying consumer complaints (including those submitted through two-way alert and complaint systems). Confirm that any product defects identified through these channels are recorded, investigated thoroughly and any necessary corrective actions taken as soon as possible.

Use our digital GMP audit checklist to assess your facility’s compliance with FDA guidelines across building and facilities, personnel, equipment, raw materials production lab controls complaints. Take notes and photos at work without leaving your workplace and easily create reports online with secure saving. Track audit performance with ease!