A company’s records are a prized possession and should be taken care of the best way possible. When we think of good manufacturing practices (GMP), regulations must be followed to keep the quality and integrity of your records in good standing. Current GMP regulations for pharmaceuticals regarding records and documents are listed in FDA code 21 CFR 211 subpart J: Records and Reports. Records keep track of what a company is doing and identify issues or situations that may arise. These records allow auditors to see what is being produced, how it is being tested, issues, corrective actions, and many other items.

Consumers like to see proof and facts about the products they intend to use, and that proof is in the documentation and records. Let’s dig a little further and see just how helpful the GMP guidelines can speak volumes. The quality assurance department will manage the record-keeping and the documentation of all records.

Record-keeping and documentation guidelines for GMP are remarkably straightforward and exceedingly precise. Let’s take the example of a batch record that has just been completed by production. Here are some of the general requirements related to the example.

  • All documents must be designed, reviewed, and distributed with care. In the example, the management department created a batch record, which the quality assurance department reviewed. Batch records can only be printed by quality assurance to ensure that the record is being given to the appropriate personnel. Thus, not everyone can print a batch record. Furthermore, this process makes sure the correct document is being used.
  • All documentation must be clear and legible. Every entry into this batch record must be written clearly to maintain integrity. Your company does not want the FDA to come in for an audit and ask for a record that they can’t read or understand what is going on.
  • All documents must be approved, signed, and dated by the appropriate personnel. For this example, when the batch record was created, the document went through a workflow of reviewers and approvers until final approval. At this point, the document was approved, signed, and dated, which allowed the batch record to become live and functional.
  • Documents must be very specific in title, content, and purpose. There cannot be documents that can be misinterpreted or used in a different process. A batch record has to be specific to what is being produced. The label must have a product name, the dosage, and the procedure used—no open-ended interpretations.
  • Documents must be reviewed and updated regularly. Your company’s standard operating procedure should state how often a document should be reviewed. Also, send that document through its workflow to get updated whenever a revision should be made. There is always something that can make things run faster or better, which is why updates occur. Also, new sets of eyes can find issues with a document, so regular reviews are necessary. You would rather have an employee notice the problem than the FDA auditor.
  • Documents must always be typed and never handwritten to prevent misreading information because it is not legible. It also controls any unnecessary corrections or changes from being made.
  • Corrections to any document or records have to be crossed out with one line, initialed, and dated at the time of correction. Another important thing to add is the reason for the correction, to clarify why the correction was needed.
  • Actions in manufacturing and the control of products must be recorded clearly for traceability. Batch records are a step-by-step process that must be followed precisely as the batch record states. After each step, initials and date should be recorded.

Record-keeping and documentation are essential to a company, and shortcuts should never be made. If the GMP guidelines are managed well, there should be no issues when audited by the FDA, who enforce GMP regulations. Any major infraction can cause the company to obtain 483’s (see Inspection Observations | FDA), which a company never wants. PSC Biotech® can help your company become compliant with your documentation by offering document review (see Document Review 101) services.

PSC Biotech® Quality Engineers specialize in QA Oversight, Gap Analyses, Training Compliance and Support, Review and Approval of Validation Documents, CAPAs, Non-Conformance Reports, Quality Agreements, and the facilitation of project documentation. We have expertise in quality compliance, audit rights, regulatory inspections, regulatory documentation, staff training, change control, qualification, investigations, deviations, production, stability, and complaints for Operations, Engineering Services, and IT Services. With over 25 years of business in regulatory compliance, contact us for all your GMP needs.

Written by Ashley Castro, PSC Biotech® Consultant

Edited by Crystal McClain, PhD

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