GMP Holding and Distribution

By: Pharma Tips | Views: 5017 | Date: 24-Apr-2011

WAREHOUSING PROCEDURES(a) Quarantine of drug products before release by the quality control unit.(b) Storage of drug products under appropriate conditions of temperature, humidity, and light so that the identity, strength, quality, and purity of the drug products are not affected.DISTRIBUTION PROCEDURESWritten procedures shall be established, and followed, describing the distribution of drug products. They shall include:


Warehousing Procedures:

(a)    Quarantine of drug products before release by the quality control unit.

(b)    Storage of drug products under appropriate conditions of temperature, humidity, and light so that the identity, strength, quality, and purity of the drug products are not affected.

Traditionally, there have been two types of warehouse storage conditions:

1.    Ambient conditions. For many products an adequate shelf-life can be determined that encompasses the relatively wide range of conditions that constitute "ambient". Local and national weather records are available which provide data on temperature ranges. Maintenance of actual temperature data in a warehouse provides the assurance that the assumptions made in determining shelf-life continue to be met.

    Humidity and light are rarely controlled, or even monitored, since, product packaging is usually designed to take these two conditions into account.

2.    Refrigerator and freeze. Certain products that are relatively unstable at ambient conditions require storage at lower temperature. Appropriate equipment or areas must be provided and the conditions monitored to confirm compliance with the prescribed storage requirements.

Distribution Procedures:

    Written procedures shall be established, and followed, describing the distribution of drug products. They shall include:

(a)    A procedure whereby the oldest approved stock of a drug product is distributed first. Deviation fro this requirement is permitted if such deviation is temporary and appropriate.

(b)    A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary.

    Distribution records must be constructed and procedures established to facilitate recall of defective product. A requisite of the system is approval and specific release of each lot of drug by the quality control function before distribution can occur. This control of finished goods for shipment allows only those drugs into commerce that have been shown by testing to conform to appropriate requirements.

    The manufacturer must maintain records of all distribution transactions involving in-process or finished goods. All records should be indexed by either the 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. This type of indexing permit an efficient determination of the receiver of a lot to be recalled since only one shipment record need be examined. Depending on the marketing procedures of the individual company, distribution records may list shipments to consignees for packaging or labeling, or to an independent distributor, a wholesaler, a retail pharmacist, a physician, or possibly the ultimate consumer.

    A variety of distribution recording systems may be utilized. Two of the more commonly used approaches are to record the lot or control number on the  retained copies of the shipping invoices or to record the dates on which each lot commenced distribution. This latter approach has disadvantages in that it does not readily accommodate the redistribution of small amounts of returned good or the occasional need to distribute part lots out of sequence.

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