Tablets & Capsules


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32F April 2018 Tablets & Capsules Materials, components, and product labels. The contractor must also establish and maintain a physical location and procedures for storing and securing materials, components, and product labels to prevent mix-ups or cross-contamination. Items must be quarantined until they have been appropriately released by the QU. The quality agreement should designate supplier selection and qualification and the corresponding specifications. The document should also indicate the authority to release materials, components, and product labels. Laboratory operations. Whether a contractor uses an in-house or third-party contract laboratory for testing, the laboratory must be qualified before use, and the OLD must receive prior written notice. The laboratory must establish and follow written procedures for laboratory operations; demonstrate that all equipment is of appropriate design and construction and is suitable for its intended use per the laboratory equipment qualification, calibration, and preventive maintenance program; use only test methods that have been determined to be scientifically valid; and document the performance of all testing and laboratory control processes at the time of performance. Finished products. The OLD must establish a finished product specification for the contractor to use, and a representative, statistical sample of the product must be tested in-house by the contractor or by a third-party contract lab to determine if the specification has been met. The quality agreement must define the authority to release the product based on the completed BPR and test results. If the contractor is responsible for the disposition of product, a certificate of analysis (COA) should be kept on file and/or provided to the OLD upon request. Shipping and distribution. The distribution date as well as the distributor's name and address must be available and traceable to the exact product batch. Records of all product shipments must be prepared and maintained in accordance to contractor procedures and made available to the OLD as necessary. T&C References 1. 21 CFR § 111.1 2. 21 CFR § 111.105 Tara Lin Couch, PhD, is senior director of dietary supplements and tobacco services at EAS Consulting Group, Alexandria, VA (571 447 5500, compiling, and reviewing that data in accordance with a stability program. Facilities and equipment. The contractor's facilities must be of suitable size, construction, and state of repair to facilitate cleaning and sanitizing operations and allow for the orderly placement of equipment and holding of materials and/or product. This is necessary for maintenance, cleaning, and sanitizing operations as well as to prevent contamination and mix-ups. All equipment should be of an appropriate design and construction and be evaluated through a procedural equipment qualification and calibration program that is reviewed by the contractor QU. The state of the contracting facility will be verified through an initial audit, but the contractor must notify the OLD of any significant changes to the facility so the OLD can assess if a follow-up audit is warranted. B o t h p a r t i e s w i l l p e r f o r m a n d m a i n t a i n a n environmental monitoring program that includes the use of swabs for microbiological contaminants and allergens as well as point-of-use water testing. The parties must also establish procedures and controls for storing and handling allergenic materials to prevent cross-contamination and a pest control program that incorporates facility inspections, extermination, or other means to limit pest contamination sources. The OLD and contractor will each have a documented personnel training program to ensure that all personnel have the education and experience to perform their assigned job functions. Initial and annual follow-up GMP training must be part of the program. When changes in key personnel occur, each party should be notified. Production Control. The quality agreement should include a master manufacturing record (MMR)—reviewed and approved by both the OLD and the contractor— dictating each step of the manufacturing and packaging process to ensure GMP compliance and adherence to the approved product formulation. The MMR should also include in-process specifications to guarantee quality. The contractor should prepare a batch production record (BPR) every time a unique batch of the product is manufactured and packaged, and the OLD QU should periodically review completed BPRs to ensure execution of the MMR. BPRs must also contain the results of tests and examinations that demonstrate the finished product quality. No rework, reprocessing, or other manipulation of the product outside of the defined process noted in the MMR should be conducted without the review and approval of both parties' QUs.

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