How do you document and keep records for GMP in product development?

1 What is GMP documentation?

GMP documentation is a collection of written policies, procedures, protocols, reports, forms, logs, and records that document the activities and results of product development. It serves multiple purposes, such as defining roles and responsibilities of the product development team and the quality assurance unit, establishing specifications and standards for the product and its components, describing methods and equipment used for product design, testing, validation, and verification, as well as recording data, observations, deviations, corrective actions, and conclusions. Furthermore, GMP documentation helps demonstrate compliance with regulations and provides a basis for review, audit, inspection, and continuous improvement.

2 How to create GMP documentation?

GMP documentation should be created with accuracy, completeness, clarity, legibility, traceability, and availability in mind. It should reflect the actual activities and results of product development without errors or omissions. All relevant information and details of product development, such as dates, signatures, references, and attachments should be included. The documentation should be written in a clear, concise, and consistent manner with simple and unambiguous language and terminology. Furthermore, it should be readable and understandable with legible handwriting or printed fonts, avoiding erasures, corrections or overwriting. It should also be identifiable and traceable with unique identifiers, version numbers, and cross-references following a logical sequence and structure. Lastly, it should be accessible and retrievable using appropriate storage and filing systems that follow a retention and disposal policy.

3 What are the types of GMP documentation?

GMP documentation can be divided into two categories: primary and secondary. Primary documentation, such as protocols, reports, forms, logs, and records, directly records the activities and results of product development. It must be approved, signed, and dated by the authorized personnel before execution or completion, and a second person should review it for accuracy and completeness. On the other hand, secondary documentation supports or supplements the primary documentation. Examples of this type of documentation include policies, procedures, manuals, guidelines, and specifications. These documents must also be approved, signed, and dated by the authorized personnel before issuance or revision. Furthermore, they should be controlled and distributed according to a document management system.

4 How to maintain GMP documentation?

GMP documentation should be maintained in accordance with a document management system that defines roles, responsibilities, procedures, and tools for creating, reviewing, approving, issuing, revising, distributing, storing, retrieving, archiving, and disposing of documentation. It should also be protected from unauthorized access or modification using physical or electronic security measures such as locks, passwords, backups and encryption. Furthermore, the documentation should be checked for quality and compliance regularly using internal or external audits, inspections or reviews. Any issues or gaps identified should be addressed and resolved promptly. Finally, the documentation should be updated and improved continuously based on feedback, changes or new requirements. Any revisions or amendments should be documented and communicated clearly.

5 Why is GMP documentation important?

GMP documentation is important for several reasons, such as demonstrating compliance with GMP and regulatory requirements, enabling traceability of the product and its components, establishing accountability of the product development team and the quality assurance unit, and capturing and preserving the knowledge and experience of product development. This can affect the approval, registration, marketability, investigations, recalls, corrective actions, liability, reputation, training, learning and innovation for future projects.

6 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?