Audit Checklist for Pharmaceutical Industry

Audits are an integral component of pharmaceutical businesses, providing an opportunity to identify areas for improvement while giving peace-of-mind that their products are safe for patients.

Verify that the marketing authorisation holder or manufacturer has implemented a procedure for reporting serious adverse medicinal product reactions. Verify if this procedure has been documented.

Quality Control
Quality control in the pharmaceutical industry is of critical importance, ensuring products meet industry standards and are safe for human consumption. Furthermore, quality assurance helps companies protect their reputation by avoiding regulatory fines or penalties imposed on them by regulators or industry organizations. Conducting regular audits helps ensure all operations comply with regulations or other industry standards.

Raw materials testing is an integral component of pharmaceutical quality control, testing raw materials and excipients to assess compliance with pharmacopoeias or monographs. If non-compliance occurs, then that material cannot be used until its issue has been addressed.

An essential aspect of quality control is investigating product complaints and serious adverse reactions, requiring both thorough documentation and appropriate follow-up. A quality management software with robust auditing capabilities like SimplerQMS can assist in this endeavor by helping manage supplier, internal, and external audits as well as tracking responsibilities and actions effectively.

Quality Assurance
No matter if it saves lives or causes irreparable harm, pharmaceutical companies must uphold high standards to meet regulatory requirements and comply with their quality assurance system. Therefore, implementing one is essential to their operations.

Quality assurance (QA) involves developing and implementing systems in all aspects of an organization to ensure goods and services meet quality, safety, and efficacy (QSE) standards set by national and international agencies. Furthermore, quality assurance helps the business avoid reputation-damaging incidents by following good manufacturing practices and creating comprehensive inspection policies.

Quality assurance professionals must stay current on the latest regulations, guidelines, and standards to identify gaps in compliance and drive data-driven decision making. This involves setting and regularly reviewing key performance indicators (KPIs) and quality metrics to measure progress against predetermined objectives. In order to be successful at their jobs as pharmaceutical QA professionals, pharmaceutical QA specialists require exceptional communication and technical abilities as well as knowledge of risk-based auditing techniques such as understanding QMSs, CAPAs, deviation processes, batch releases and root cause analyses processes of their company.

Documentation
Documentation in the pharmaceutical industry is a comprehensive process designed to ensure compliance with legal standards and regulatory guidelines, such as verification of documents, records and quality data collection systems. Furthermore, documentation can help identify issues raised during auditing processes as well as determine strategies to respond accordingly.

cGMP regulations mandate that manufacturers of pharmaceuticals and medical devices adhere to detailed documentation standards during manufacturing, in order to minimize cross-contamination risks while assuring high-quality product reaches consumers in perfect condition.

Requirements like these are integral in ensuring the public receives high-quality, safe medications and medical devices from pharmaceutical companies. A systematic pharmaceutical auditing system must exist; with SafetyCulture (formerly iAuditor), performing pharmaceutical audits is easy while all inspections are recorded properly and stored safely.

Complaint Handling
Complaint management is an integral component of pharmaceutical businesses. Not only can it ensure compliance with industry practices and regulations, but also helps cultivate stronger customer relationships.

Pharmaceutical manufacturers must establish and implement stringent procedures for handling customer complaints, which must include conducting an in-depth investigation for each complaint and documenting their resolution in a log of closed cases. Furthermore, this process should involve all departments including Quality Assurance, Finance, Production Marketing and Regulatory Affairs as part of an inclusive approach.

At audits, auditors will pose various queries to your company regarding its processes and documentation. You should answer honestly yet professionally to allow auditors to gain an accurate assessment of your company’s quality standards. A simplerQMS document management system may be an ideal way of keeping all documents digitalized and organized according to pharmaceutical industry requirements.