GMPo DISTRIBUTIONo DISTRIBUTION RECORDo HANDLING OF RETURNED GOODSo RECOVERY & REPROCESSING MATERIALGUIDED BY: PRESENTED BY:Mr. PRATIK NAYAK DESAI YAD M. M.PHARM (Q.A) SEM-1
Distribution procedures Written procedures shall be established and followed, describing the distribution of drug products. They shall include: A procedure whereby the oldest approved stock of a drug product is distributed first. A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary.
Distribution record must be constructed and procedures established to facilitate recall of defective product. Manufacturer must maintain record of all distribution transactions involving in process or finished goods. All record should be indexed by either manufacturing batch-lot number of the packaging control number as a means of accountability until the shipment passes from the direct control of the manufacturer.
The distribution process also include other considerations, it must be arranged so that a first in /first out movement of product occurs. These requirement is consistent with the intent of the stability and expiration dating policy.
APIs should only be released for distribution to third parties after they have been released by the quality unit. APIs may be transferred under quarantine to another unit under the company’s control when authorized by the quality unit and providing appropriate controls and documentation are in place. APIs should be transported in a manner that does not adversely affect their quality. Special transport or storage conditions for an API should be stated on the label.
The API manufacturer should ensure that the contractor for transportation of the API knows and follows the appropriate transport and storage conditions. A system should be in place by which the distribution of each batch of intermediate and/or API can be readily determined to permit its recall.
DESTRIBUTION RECORD Distribution records shall contain the name and strength of the product and description of the dosage form, name and address of the consignee, date and quantity shipped, and lot or control number of the drug product. For compressed medical gas products, distribution records are not required to contain lot or control numbers. The primary purpose of this section is to ensure that adequate data are available to access trade customers should a recall be initiated.
Distribution records include a wide range of documentation such as invoices, bills of lading customers’ receipts, and internal warehouse storage and inventory records. The information required need not be on every document. Also customer codes and product codes may be used as alternates to customer names and addresses and product names. Records for distribution shall be maintained in a manner such that finished batch of a drug can be traced to the retain level to facilitate prompt and complete recall of the batch, if and when necessary.
Handling of Returns Goods Finished product may be returned to the company or its Authorized nominees for one or the other reasons. Such returned goods may either be destroyed or reconditioned and made it for use. Clear guidelines in this regard must therefore exist and be followed. Head of quality control shall be primarily responsible to formulate detailed procedures for dealing with the handing of return goods and implement this procedure.
For each return, documentation should include: Name and address of the consignee , Intermediate or API, batch number, and quantity returned, Reason for return, Use or disposal of the returned intermediate or API.
Returned drug products shall be identified as such and held. If the conditions under which returned drug products have been held, stored, or shipped before or during their return, or if the condition of the drug product, its container, carton, or labeling, as a result of storage or shipping, casts doubts on the safety, identity, strength, quality or purity of the drug product, the returned drug product shall be destroyed unless examination, testing or other investigations prove the drug product meets appropriate standards of safety, identity, strength, quality, or purity.
Products returned from the market should be destroyed unless it is certain that their quality is satisfactory; in such cases they may be considered for resale or relabeling, or alternative action taken only after they have been critically assessed by the quality control function in accordance with a written procedure. A drug product may be reprocessed provided the subsequent drug product meets appropriate standards, specifications, and characteristics.
RECOVERY & REPROCESSING MATERIAL Introducing an intermediate or API, including one that does not conform to standards or specifications , back into the process and reprocessing by repeating a crystallization step or other appropriate chemical or physical manipulation steps (e.g., distillation, filtration, chromatography, milling) that are part of the established manufacturing process is generally considered acceptable. If such reprocessing is used for a majority of batches, such reprocessing should be included as part of the standard manufacturing process.
Such reprocessing should be preceded by careful evaluation to ensure that the quality of the intermediate or API is not adversely affected due to the potential formation of by products and over-reacted materials. Recovery of reactants, intermediates, or the API is considered acceptable, provided that approved procedures exist for the recovery and the recovered materials meet specifications suitable for their intended use.
Solvents can be recovered and reused in the same processes or in different processes, provided that the recovery procedures are controlled and monitored to ensure that solvents meet appropriate standards before reuse or commingling with other approved materials. Fresh and recovered solvents and reagents can be combined if adequate testing has shown their suitability for a manufacturing processes in which they may be used. The use of recovered solvents, mother liquors, and other recovered materials should be adequately documented.
REFERENCES Sidney H. Willing, “Good Manufacturing Practice for Pharmaceuticals” Marcel Dekker, Page no 132 www.fda.gov/downloads/.../Guidance/ucm129098.pdf D .H. SHAH “QA MANUAL” , First edition, Business horizons publication, page no: 152,156, 180, 181