Regulatory approval is an achievement for a pharmaceutical industry. To get the approval for highly regulated market a pre-approval inspection is performed by the respective regulatory body. Here we try to mention a checklist for regulatory inspection but it's not limited to the below list.
For pharmaceutical manufacturer
- The inspection plan/agenda.
- GMP certification.
- Manufacturing authorization or registration number.
- A procedure to notify the regulatory authority of significant changes or of conditions, which may affect the quality, safety or efficacy of a medicinal product.
- The manufacturing authorization information (the address of each site, the manufacturing activities, the category of medicinal product, and the dosage form).
- A policy/guideline exists that details situations regarded as Code of Conduct.
- The GMP regulatory framework (quality management, premises, equipment, personnel, sanitation, raw material testing, manufacturing control, quality control department, complaints, product recalls, packaging material testing, finished product testing, records, samples, stability and sterile products).
- Updated SOPs.
- Critical stages and parameters of manufacturing processes.
- All product defects reported are documented and investigated.
- Qualification and validation of equipment and machineries.
- OOS/OOT/Deviation handling procedure.
- Good laboratory practices.
- Data integrity confirmation.
- A documentation control system is in place.
- Signature and Delegation Log.
- The test method validation guideline is equivalent to the ICH standard.
- The qualifications of staff.
- The quality management system is based on a recognized international standard.
- A training programme is established and records are maintained.
- A mechanism to evaluate the effectiveness of training exists.
- A procedure details the requirements for post-inspection activities, and is followed.
- A consumer complaint system/procedure.
- Recall procedures/mechanisms.
- Recent audit observation and CAPA.
For inspector
- A procedure details the requirements for pre-inspection activities, and is followed.
- A procedure details the requirements for conducting inspections, and is followed.
- The inspection plan is based on the company’s GMP compliance history, critical activities and type(s) of dosage forms or products manufactured.
- A procedure for the format and content of inspection reports is available.
- Observations are factual and are based on proper interpretation of applicable legislation.
- Observations are classified/categorized according to risk.
- Assessment of the company’s overall compliance status is in line with the inspection findings.
- Inspection reports are completed in the required reporting format and timeframe.
- Inspection findings and conclusions.
