GMP Compliance

GMP Document Management Compliance

What is the GMP?

GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act. These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This in turn, protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.

GMP regulations address issues including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business.


Documentation and records for GMP compliance

The basic rules in any good manufacturing practice (GMP) regulations specify that the pharmaceutical manufacturer must maintain proper documentation and records. Documentation helps to build up a detailed picture of what a manufacturing function has done in the past and what it is doing now and, thus, it provides a basis for planning what it is going to do in the future. Regulatory inspectors, during their inspections of manufacturing sites, often spend much time examining a company’s documents and records. Effective documentation enhances the visibility of the quality assurance system. It is an essential part of GMP to keep accurate records, and during an audit it helps convey the message that procedures are being followed. It also demonstrates that the processes are known and are under control.

What are the various types of documents that a GMP facility need to maintain?

Given below is a list of the most common types of documents that a GMP facility need to maintain

  • Quality manual: A global company document that describes the regulations that the company is required to follow.
  • Policies: Documents that describe in general terms how specific GMP aspects will be implemented.
  • Standard operating procedures (SOPs): Step-by-step instructions for performing operational tasks or activities.
  • Batch records: Documents maintained by the manufacturing department with step-by-step instructions for production-related tasks and activities
  • Test methods: Documents completed by the QC department with step-by-step instructions for testing supplies, materials, products, and other production-related tasks and activities of the GMP facility.
  • Specifications: Documents that list the requirements that a supply, material, or product must meet before being released for use or sale.
  • Logbooks: Bound collection of forms used to document activities of operation, maintenance, calibration of a piece of equipment and record critical activities, change controls and its corrective action assignment.

The organization should establish a hierarchical document system as shown below:

File structure for GMP Compliance


What is a document management system and how can it help with GMP compliance?

A document management system stores, retrieves, manages and tracks electronic documents and electronic images of scanned paper-based information, tracks document lifecycle and audit trail and ensures timely approval of documents via automated document workflows. A document management software ultimately controls and organizes documents throughout an organization.

Let's get you started by asking you the following questions on how you are currently handling your documents:

  1. Are all documents passing through appropriate review and approval procedure?
  2. Are distribution records maintained for all documents?
  3. Is there any procedure for ensuring that the current version of the documents are being used?
  4. Is history of changes made in documents maintained?
  5. Does document control procedure include the procedure for handling obsolete versions?
  6. Does the storage/archival of documents provide a suitable environment to minimize deterioration or damage to quality-related documents?
  7. Is there a system for periodic review of documents?
  8. Is there a document control system available for managing your SOPs?
  9. Are all quality-related documents being retained for history?
  10. Is preventive maintenance activity being recorded in the logbook? Or is there any other appropriate documentation?
  11. Are electronic signatures used? If yes, is there an adequate control or security measure?
  12. Is there a system to determine customer requirements related to the product and supply of the product?
  13. Is there a procedure in place to assure that the manufacturer and the customer have mutually agreed upon the specifications and other requirements?
  14. Are specifications for all material available with QC and user department?

If your answer to the above questions is a "NO", you definitely need a document management system to manage your documents and ensure GMP Compliance. If you do not manage your documents now, you will end up in the risk of paying huge fines for non-compliance.

LuitBiz DMS can help comply with GMP compliance that are pertaining to document management. Let’s take a look at some of the key elements of the GMP and how LuitBiz DMS addresses them:

Chapter What it means How LuitBiz DMS helps
Audit Trail
All documents related to the manufacture of intermediates or APIs should be prepared, reviewed, approved, and distributed according to written procedures. Such documents can be in paper or electronic form. LuitBiz DMS provides full audit trail of all actions within the repository that can’t be accessed or modified by any user.
Version Control
The issuance, revision, superseding, and withdrawal of all documents should be controlled by maintaining revision histories. LuitBiz DMS has a built-in version control system that helps manage versions and historical records of all document versions.
6.12 & 6.13
Records Retention
A procedure should be established for retaining all appropriate documents and the retention periods for these documents should be specified. LuitBiz DMS has a feature to define document retention period for different groups of documents and alerts for their deletion on completion of their retention period. Hence, all production, control, and distribution records can be retained for at least 1 year after the expiry date of the batch and for APIs with retest dates, records can be retained for at least 3 years after the batch is completely distributed and these can all be configured in LuitBiz DMS.
Document In Original Format
Specifications, instructions, procedures, and records can be retained either as originals or as true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records. Where reduction techniques such as microfilming or electronic records are used, suitable retrieval equipment and a means to produce a hard copy should be readily available. LuitBiz DMS stores files in their original format and hard copies can be printed out whenever necessary. Documents can be arranged in the 4-level folder structure as specified by the GMP regulations and user access rights can be given to the documents at the folder level.
Specification Records
Specifications should be established and documented for raw materials, intermediates where necessary, APIs, and labeling and packaging materials. In addition, specifications may be appropriate for certain other materials, such as process aids, gaskets, or other materials used during the production of intermediates or APIs that could critically affect quality. Acceptance criteria should be established and documented for in-process controls. LuitBiz DMS allows group leaders to define in-process controls in the form of document tagging to specify information fields that need to be collected for raw materials, intermediates, APIs, and labeling and packaging materials. These information can be filled out and attached to the documents. Document search can also be performed on the values of these fields which makes document retrieval very fast and easy.
Change Control
Complete records should also be maintained for any modifications to an established analytical method, periodic calibration of laboratory instruments, apparatus, gauges, and recording devices, all stability testing performed on APIs and out-of-specification (OOS) investigations LuitBiz DMS provides all of these document change control features.