GMP Audit Checklist For Pharmaceutical Industry

Regulatory agencies conduct GMP audits to help ensure the quality and safety of pharmaceutical products, which includes inspections of facilities, systems, personnel and warehouses to check for tamper-evident packaging as well as compliance with holding conditions during storage.

GMP rules cover everything from initial facility design to test procedures, measurement results, record keeping systems and production methods – they even apply to company pens, ditto marks and post-it notes!

1. Documentation
GMP compliance improves product consistency, helps maintain safety standards and protect public health. Companies achieving GMP compliance must establish documented evidence that their process consistently produces a quality product; this may involve development or scale-up activities as well as process validation and change control activities.

Companies should also implement written procedures for equipment calibration, maintenance and cleaning; as well as keeping records of QC checks. Regular reviews by personnel of such procedures should ensure their effectiveness.

Any noncompliance findings during an inspection must be reported to a competent authority in Europe and included in the EudraGMDP database, which is publicly accessible. An inspection can result in changes or cancellation of manufacturing or import authorization (MA) issued by European authorities.

2. Training
GMP (Good Manufacturing Practices) requires stringent guidelines regarding facility design and maintenance, equipment and utilities use, product testing and record keeping. GMP also applies to personnel training as well as continual reviews of manufacturing processes to protect patients while building public trust in pharmaceutical manufacturing processes. Such systems protect patients while simultaneously upholding public confidence in pharmaceutical production.

Regulatory agencies conduct GMP audits of facilities, systems and SOPs to ensure compliance with international quality standards. These include the FDA, EMA, CBER and various regional/local government health departments.

GMP inspections are typically requested as part of the assessment, approval and maintenance processes associated with Marketing Authorizations (MAs) or Centrally Approved Medicinal Products (CPMPs). In such instances, either the holder of manufacturing authorization for human or veterinary medicines placed on the market, or EU importers for active substances must verify compliance directly or through third parties acting under contract with manufacturers to GMP standards.

3. Maintenance
Compliance with Good Manufacturing Practice (GMP) standards provides consistency and safety in products manufactured, maintains quality standards and safeguards public health. Regulators agencies such as FDA and TGA conduct regular inspections of pharmaceutical manufacturers to ensure GMP is upheld.

Inspectors conducting GMP audits review many aspects of the manufacturing process, from facilities and equipment, raw materials, production processes, lab controls, record keeping and labelling to validating processes.

GMP audits are an integral component of quality control in any pharmaceutical, medical device or food manufacturing facility. A successful audit can ensure regulatory compliance while building customer confidence in its products.

4. Equipment
GMP requires that pharmaceutical and medical device manufacturing operations adhere to stringent quality and safety standards in order to avoid recalls or facility shutdowns, but to protect themselves they should regularly practice self-inspections, equipment validation and create an appropriate CAPA system in place for investigations and corrections of deviations that arise during production processes.

EMA and national inspectors collaborate to promote cooperation with regulators outside of the EU by sharing inspection-related information through EudraGMDP database’s planning module, in order to reduce duplication and optimize resource use. In addition, EMA provides training sessions for GMP/GDP inspectors from EEA countries and accession states.

5. Personnel
GMPs govern everything that occurs within a pharmaceutical facility, beginning with initial facility and cleanroom engineering designs to testing procedures, measurement results reporting systems and records processing systems. GMPs also encompass pharmacovigilance systems for handling complaints or adverse events.

Successful GMP audits are essential to maintaining compliance and building customer trust for your products, so it is imperative that you prepare well in advance for an audit.

Reread GMP regulations and become familiar with any recent modifications. Make sure all necessary personnel are available and book their calendars for an audit, while electronic documents should also be ready so as not to hold up the auditor while someone retrieves documents.