How to Do GMP Audit

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Questionnaire for GMP Audit perform yearly

A questionnaire for GMP audit performed yearly is a tool that can help to assess the compliance of a pharmaceutical manufacturing facility with the good manufacturing practice (GMP) standards and regulations. A questionnaire can cover various aspects of the GMP requirements, such as personnel, premises, equipment, materials, production, quality control, documentation, contract manufacturing, complaints, recalls, self-inspection, validation, change control, etc. A questionnaire can also be tailored to specific types of products or processes, such as sterile products, active pharmaceutical ingredients (APIs), or excipients.

A questionnaire can be used by both internal and external auditors to prepare and conduct a GMP audit. A questionnaire can help to identify the scope and objectives of the audit, the areas and processes to be audited, the documents and records to be reviewed, the questions to be asked, and the evidence to be collected. A questionnaire can also help to evaluate the findings and observations of the audit, and to generate a report and recommendations for improvement.

There are different sources of GMP audit questionnaires that can be used as references or templates for creating a customized questionnaire. Some of these sources are:

● Questionnaire for preparing GMP-inspections: This is a book that contains more than 650 typical questions related to audits and inspections. Each question has a reference to the current EU GMP Guide Part I/II and the 21 CFRs 210/211/11. The book is intended for auditors and manufacturers of drugs and APIs.

● GMP Audit Checklist for Drug Manufacturers: This is a checklist that is intended to aid in the systematic audit of a facility that manufactures drug components or finished products. The checklist has references to sections in the GMP regulation. The checklist is provided by ISPE (International Society for Pharmaceutical Engineering).

● GDP Audit Questionnaire for the Transport and Storage of Medicinal Products: This is a book that contains more than 700 questions with references to GMP/GDP regulations and EN ISO 13485 on the preparation and implementation of GDP audits. The book is intended for auditors and manufacturers of medicinal products.

● Auditing Guide - Pre-Audit Questionnaire: This is a questionnaire that is intended to assist in preparing an audit plan. The questionnaire covers general information about the company, its products, its quality system, its personnel, its facilities, its equipment, its materials, its production, its quality control, its documentation, its contract manufacturing, its complaints and recalls, its self-inspection, its validation, and its change control. The questionnaire is provided by ECA (European Compliance Academy).

● Self-Assessment Questionnaire on Good Manufacturing Practice. This is a questionnaire that is designed to accompany the Food Supplements Europe (FSE) publication ‘Guide to Good Manufacturing Practice for Manufacturers of Food Supplements’. The questionnaire aims to assist a company with assessing their current GMP status and to highlight any areas where further efforts to raise the GMP standard may be required.