Pharmaceutical Quality Control Audit Checklist

Pharmaceutical quality control audit checklists are one of the tools many companies rely on to maintain regulatory compliance and uphold current Good Manufacturing Practice (cGMP) standards.

Review the manufacturer’s documentation of drug substance, such as purity tests and charts. Evaluate the CGMP’s in-process testing plan, analytical methods, and specifications for further review.

Guarantee that any complaints or information about quality defects is recorded, investigated and documented by marketing authorisation holders.

1. Documentation
Undergoing regular pharmaceutical audits is essential to ensuring effective internal quality controls are in place, including laboratory controls, inspection of raw materials and in-process products, as well as a well-documented process to assess and approve or reject materials and products for production use.

Verify that there is a procedure in place outlined the process for compiling the surveillance sampling plan for APIs and medicinal products across their entire distribution chain and dosage forms, including inbound products from suppliers as well as outgoing batches to customers. This should involve monitoring both batches incoming from suppliers as well as outgoing batches from customers.

Verify that an effective system has been put in place for managing quality defects within defined timelines, with appropriate Key Performance Indicators set. Also ensure a process has been put in place for regularly testing and updating two-way alert systems, along with records being readily available.

2. Process Controls
This aspect of the pharmaceutical quality control audit checklist covers additional documentation, testing, and complaint handling procedures. Pharmaceutical manufacturers should have robust procedures in place for investigating and responding to product complaints promptly and equitably.

Verifying that there are procedures in place for sampling, testing and handling raw materials, packaging material, in-process drugs and bulk drug products as well as finished products is of critical importance. There should also be documented processes for the identification, strength purity and consistency analysis of samples collected during these processes.

Inspectors should ensure there are records for every injection taken during production. These should include dates and descriptions of what was injected as well as information on who performed them and their technician name. Records should be stored securely away from public view and original work sheets should always be retained.

3. Analytical Controls
Quality in the pharmaceutical industry starts in the lab. Stringent internal controls must be implemented in order to measure, test and analyse raw materials and finished products – these measures ensure consistency across batches from different manufacturers and across manufacturers.

Analytical Quality Control (AQC) refers to a set of procedures used to ensure an analytical method produces repeatable results. AQC begins with specifying laboratory services, equipment, glassware, reagents, solvents, calibration standards and reference samples, then regularly monitoring performance through evaluation to ensure valid data continues being produced over time.

The Facilities portion of a Pharmaceutical Audit Template addresses general Good Manufacturing Practice questions and focuses on making sure the facility layout prevents contamination, has sufficient floor space and atmosphere controls that are suitable for manufacturing pharma products. In addition, this section assesses security against industrial espionage or any threats against security while product control and complaint handling features are specific to pharmaceutical operations.

4. Complaint Handling
Complaint Management Checklist ensures that customer complaints are thoroughly and promptly investigated and taken into consideration, while documenting results as well as corrective actions taken.

This section of the checklist addresses product documentation, quality assurance through sample testing, and various other items. For instance, it should provide details regarding how medical exams are conducted to evaluate product safety.

Medical device companies recognize the importance of properly reviewing, evaluating, and investigating customer complaints. Even when handled off-site by third-party teams, their records must still be available to regulatory authorities. As such, many opt for software like Greenlight Guru’s medical device quality management system which makes managing regulatory compliance simple – such as its FDA QSR compliance checklist software or ISO 13485 quality system which are both designed specifically to keep an eye on these processes – Greenlight Guru provides such tools that make managing customer service complaints, reviewing reports, evaluating reports as well as investigating issues quickly and efficiently.