cGMP Audit Checklist

The requirements and standards governing Good Manufacturing Practice (cGMP) place great emphasis on personnel. Personnel errors, oversight and unsafe or subpar work practices pose the greatest danger to quality products.

Utilize this digital GMP checklist to assess your facility or company against FDA guidelines across premises and equipment, personnel, raw materials, documentation, supplier operations, complaints & recalls, complaints & recalls and more. Take notes, snap photos and calculate scores quickly without leaving your office! Create a comprehensive report without ever leaving work!

Premises & Equipment
GMP audits are comprehensive assessments of facilities and equipment used in pharmaceutical production. This type of audit typically involves conducting tours around facilities as well as document evaluation based on applicable regulations. An external independent auditor conducts this type of review, either prearranged or unannounced.

Before an auditor arrives at your facility, filling out and completing an inspection checklist can help alleviate any unexpected surprises and avoid potential misunderstandings between auditor and company. Answer each of the checklist’s questions using either “X for no”, “C for yes”, or “n/a”. Keep an audit log book to record responses with dates, times and names of departments being audited.

Use our digital GDP Self Inspection Checklist to evaluate compliance with EU Good Distribution Practice guidelines across buildings & facilities, personnel, documents, raw materials production lab controls complaints & transport. Take photos & notes for each item while automatically calculating an audit score and creating a complete report without leaving your manufacturing site.

Cleanliness
Are raw products, work in progress, ingredients (including ice), finished product and food contact packaging stored to avoid cross contamination and spoilage? Are rejected or on hold materials clearly identified and separated from other materials? Is the facility clean throughout including its roof? Enter responses using these conventions: X = no; checkmark = yes; not applicable = not applicable; and an asterisk + notebook page number are recorded comments during auditing process.

Personnel
GMP audits include reviews at all levels of hierarchy to ensure all employees understand and comply with manufacturing standards. A detailed checklist includes inspecting workspaces and equipment cleanliness; operational methods & practices, PPE, building & ground areas pest control as well as response times for complaints, adverse events or customer inquiries.

SafetyCulture makes conducting your own inspections a breeze with its GMP audit template and mobile app, SafetyCulture. Simply take notes, capture photo evidence, calculate audit scores automatically and generate reports right from your phone or tablet – all reports can then be stored securely in the cloud for safekeeping. Start your journey for free with small teams or upgrade for unlimited reports and storage capacity.

Documentation
An effective GMP audit checklist must also assess the quality of documentation and records. This means checking for attributable, legible contemporaneously recorded original or true copy documentation that cannot be altered by anyone with power to alter specifications, manufacturing methods or any other aspect of product production. Additionally, access should be limited from those who could alter its specifications, manufacturing methods or any other aspect.

GMP inspection checklists must include questions to determine whether all facilities and plant areas are free from pests (insects, rodents, birds, reptiles or mammals). Is storage area for raw materials and finished products adequately planned to separate products from ingredients? Are rejected or on hold materials clearly marked?

Jona Tarlengco is a content writer at SafetyCulture, and since 2018 has been covering food safety, quality, and food service topics. Her writing draws upon thorough industry-related news analysis as well as Jona’s meticulous attention to detail; Jona believes the key to successful writing lies in consistency and attention to detail – her goal being providing readers with insightful perspectives they may not have considered previously.