Documentation: How to Comply with cGMP Requirements
Documentation and Records In order to comply with the GMP rules for documentation, companies should follow these general guidelines: • Prepare all documents according to procedure • Record revision history or withdrawal of documents • Retain records for: – 1 year after batch expiry date – 3 years for APIs with retest dates or OTC with no expiry dates • Ensure entries are legible, dated and signed • Specifications, instructions, etc. can be originals or photocopies/microfiche/microfilm • Make documents readily retrievable from a source • Specifications must be present for raw materials, APIs/intermediates and labeling/packaging • Authenticate and secure electronic signatures
Master Production and Control Records • Master production and control records are required to keep uniformity from batch to batch • These should be prepared, dated and signed by one person within quality unit • Master Production Instructions should include the following: – Name and/or reference code of API/intermediate – Complete list of raw materials – Quantity, ratio or calculation of batch size for each raw material used – Location of major equipment to be used – Detailed instructions for sequences, range of parameters, sampling instructions, in-process controls, time limits for completion and yield ranges at appropriate phases – Instructions for storage of materials
Batch Production Records • Batch production records are those records prepared during the manufacture of each batch of API or intermediate
• Documentation of each step in the process should include: – Dates, times (where appropriate) and major equipment used – Identification of the batch including weights, measures, and batch number – Results for critical process parameters – Signatures of persons performing and supervising the process steps – Actual yields along with deviations and their investigation results – Results of both release testing and lab testing – Official label of API/intermediate
Laboratory Control Records • Laboratory control records should have complete sets of data from all tests conducted including: – Material name, batch number, date taken, quantity and date tested for samples – Statement of each test method used – Weight and measure of the samples used for each test – Complete record of raw data generated and calculations performed during each test – Test results including how they compare to established criteria – Instructions for storage of materials – Signature of persons performing testing and review
Want to learn more about cGMPs, its requirements and best practices to comply with them? ComplianceOnline webinars and seminars are a great training resource. Check out the following links: • Current Good Manufacturing Practices • cGMPs for Medical Devices, including In Vitro Diagnostic Devices • FDA's Current Thinking for Industry cGMPs for Phase 1 INDs • GMP Compliance for Quality Control and Contract Laboratories • GMP AuditorTraining for Pharmaceutical Companies • How to Avoid GMP Non-Compliance Due to Raw Material Issues