High Standards of Compliance in the Biorepository
Introduction
Biorepository and off-site GMP storage providers take great pride in knowing that customers are receiving the best service possible. Quality management encompassing the FDA’s Good Manufacturing Practices (“GMP”) and Good Documentation Practices (“GDP”) is central to meeting and exceeding customer expectations and regulatory requirements. One aspect of this is the emphasis put on developing and executing thorough, easy-to-follow operational procedures governed by a dedicated quality department. These documented procedures enable biorepository staff to provide consistent, high-quality results to customers, regardless of which individuals perform the work. This ensures peace of mind to the clients, allowing them to focus on developing and manufacturing life-saving products.
While many operational processes and documents are in place at a GMP storage facility, some of the most important are:
- Standard Operating Procedures (“SOPs”)
Procedure documents are the backbone of our day-to-day functions. These documents control the steps employees perform in clear, concise detail. As a result, best practices are applied to every operation, regardless of the customer, method, or individual employee performing the work. This level of consistency ensures regulatory compliance while letting customers rest easy, assured that their needs are being attended to whether it is a regular day, the middle of a global pandemic or other unforeseen event. - Incoming and Outgoing Shipment Records
The biopharma storage team should carefully enter and review daily shipments for incoming and outgoing products to prevent errors in documentation. The customer forms process must include an independent review for data accuracy, integrity, legibility, and synchronous input. All documentation is then securely stored, accessible for internal and customer audits. - Documented Cleaning Procedures
Keeping thorough records of facility cleanliness activities on a weekly, monthly and annual basis along with pest control records are essential pieces of compliance within the biorepository. Customers will have peace of mind knowing their product is always kept in a clean and tidy environment, preventing damage or contamination. - Inventory Verifications and Inventory Database
A validated inventory system that is accurate and accessible to the customer in real-time via a secure web portal is crucial for transparency in a biostorage facility. The portal and inventory database must be 21 CFR Part 11 and GAMP5 compliant, ensuring that data integrity and security are maintained throughout the storage lifecycle. Keeping all customer items bar-coded and segregated as necessary, ensures all inventory is accounted for.
Conclusion
The goal of any biorepository or GMP storage facility is to provide biopharma storage customers with the highest quality service, providing peace of mind. Well-documented operations policies ensure that every customer item is handled and stored with the utmost care. Well-documented SOPs, detailed shipment records, cleaning processes, pest control records, and a robust inventory management system ensure that all work is performed on behalf of customers in a consistent, high-quality manner. These processes reassure customers that their valuable APIs, finished drug products, vaccines and other materials are in good hands regardless of which individuals are performing the work on any given day.