Why Records Management is critical for Pharma companies?
If it isn’t documented, it wasn’t done! You must have heard it many times in your career. In a records room, a direct corollary to the above statement is this – If it cannot be found, it never existed! This is exactly true for any documents that get lost in your organisation. Your auditors will not be happy if you are not able to provide the records they are looking for.
Your records room operations are direct evidence to the fact that you follow the GMP processes rigorously. If your records room operations are not as per Record Keeping and Record Management Practices in GMP then it could lead to losing your FDA license and lawsuits because of defective products, possible recalls, and harm to patients; ultimately harming your organisation which can be easily avoided by following best practices for records management.
Good Manufacturing Practices
Good Manufacturing Practices (GMP) is a system that ensures manufacturing products, such as food, cosmetics, and pharmaceutical goods, are consistently produced and controlled according to set quality standards. Any manufacturing process especially very complicated processes used in pharmaceutical manufacturing, has risks associated with it. Such risks are essentially of two types: cross-contamination (in particular, with unexpected contaminants) and mix-ups (for example, wrong labelling). GMPs ensure that every aspect of your manufacturing process is thoroughly assessed to protect against any risks that can result in catastrophic outcomes for your organisation. Implementing GMP makes immense sense, as it can help cut down on losses and waste and protect both the company and consumer from negative pharma safety events.
What has Records Management got to do with GMP?
Globally you will find many official regulations, codes and guidelines, both national and international, for GMP for pharmaceutical products. The following are the most notable and most frequently referenced:
- The US Current Good Manufacturing Practices for Finished Pharmaceuticals regulations (the US cGMPs).
- The Guide to Good Manufacturing Practice for Medicinal Products of the European Union (the EC GMP Guide).
- The ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
- Schedule M ‘Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products,’ The Drugs and Cosmetics Act and Rules, India.
- The World Health Organization (WHO) good manufacturing practices.
All GMPs mentioned above require detailed records to be maintained at each stage of the manufacturing process. Good documentation constitutes an essential part of the quality assurance system. Documentation is a critical and important aspect of GMP compliance as it ensures that all development, manufacturing and testing activities can be traced. That’s why records management is an important part of any GMP. Your auditors will be able to evaluate the overall quality of operations by looking at the records or documentation maintained in your records room. It is critical that all records are maintained in a systematic manner such that each record can be traced and located easily.
The 10 golden rules of GMP
Following are the 10 golden rules of GMP:
- Get the facility design right from the start
- Validate processes
- Write good procedures and follow them
- Identify who does what
- Keep good records
- Train and develop staff
- Practice good hygiene
- Maintain facilities and equipment
- Build quality into the whole product lifecycle
- Perform regular audits
Rule No. 3 and 5 describe the importance of documentation and records.
Importance of record keeping:
- The manufacturing and testing records (along with product retention samples) are all that remain once a batch is released.
- These records are the only real source of information on a batch after it has been released, so they must be accurate and complete.
- They provide legal evidence that the company followed GMP.
- There are many cases where in a legal dispute, the GMP-related records are used in court to verify that the company followed GMP.
- They are used to investigate product complaints/adverse events.
- Complaint investigation is a critical activity to protect patients’ health. If the records are not accurate and complete, incorrect conclusions may be made about the problem.
- They are used to investigate trends or problems.
- Often, production or product history need to be checked for trends. This can only be done if the records are accurate and complete.
- They are always reviewed during government audits.
- Auditors review records to ensure they are accurate and complete and follow GMP. They place importance on this review when forming opinions on company GMP standards.
Why you require DocPro Records Management Software?
DocPro RMS is a proven records management software that immediately gives you the capability of GMP prescribed records management practices for your record keeping. You know where your records are, who has them and who authorised their access.
DocPro RMS gives you complete control on the life cycle of your records from creation, archival to destruction. Ask for a demo now.
Advantages of DocPro Records Management System
Manual Records Management
DocPro Records Management
|Error prone processes. Increased cost of rework and lost productivity.||Best practices are implemented implicitly when you use DocPro RMS. Improved productivity.|
|Important documents and files get misplaced or permanently lost.||No fear of losing your critical documents ever.|
|Searching takes time. Dependent on human memory or using spreadsheets which is error prone.||Tracking of all documents at your fingertips. Quick Search and retrieval.|
|Highly dependent on the person in charge of records room. Prone to human errors.||No dependency on personnel. DocPro RMS ensures processes are followed.|
|No audit trail available.||Every activity is maintained in the audit log.|
|No alerts and notifications.||Alerts and notifications for exceptions.|
Add, search and track items (files/folders/containers)
Fast and easy search and retrieval
Submission of requests to Records Room by users
Approval by authorized users for requests
Strong access control for information security
Add items to locations, move item to other location
Barcode capability allows fast and easy operations
Real time information of work order status
Bulk data import for new items, re-filing items, item and location movement
Process for planned destruction of records
Audit trail of every activity from creation to destruction of records
Bulk operations like bulk retrieval for auditing purposes