Materials - Intermediate & Bulk Products, Finished Products

Sathyanarayana M.Sc.

Materials - Intermediate & Bulk Products, Finished Products

Intermediate and Bulk Products:

14.24   Intermediate and bulk products should be kept under appropriate conditions.

14.25   Intermediate and bulk products purchased as such should be handled on receipt as though they were starting materials.

Finished Products:

14.26   Finished products should be held in quarantine until their final release, after which they should be stored as usable stock under conditions established by the manufacturer.

14.27   The evaluation of finished products and the documentation necessary for release of a product for sale are described in section 17, “Good practices in quality control”.

Rejected, Recovered, Reprocessed and Reworked Materials:

14.28   Rejected materials and products should be clearly marked as such and stored separately in restricted areas. They should either be returned to the suppliers or, where appropriate, reprocessed or destroyed in a timely manner. Whatever action is taken should be approved by authorized personnel and recorded.

14.29   The reworking or recovery of rejected products should be exceptional. It is permitted only if the quality of the final product is not affected, if  the specifications are met, and if it is done in accordance with a defined and authorized procedure after evaluation of the risks involved. A record should be kept of the reworking or recovery. A reworked batch should be given a new batch number.

14.30   The introduction of all or part of earlier batches, conforming to the required quality standards, into a batch of the same product at a defined stage of manufacture should be authorized beforehand. This recovery should be carried out in accordance with a defined procedure after evaluation of the risks involved, including any possible effect on shelf-life. The recovery should be recorded.

14.31   The need for additional testing of any finished product that has been reprocessed, reworked or into which a recovered product has been incorporated, should be considered by the QC department.

Recalled Products:

14.32   Recalled products should be identified and stored separately in a secure area until a decision is taken on their fate. This decision should be made as soon as possible.

Returned Goods:

14.33   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 relabelling, or alternative action taken only after they have been critically assessed by the QC function in accordance with a written procedure. The nature of the product, any special storage conditions it requires, its condition and history, and the time elapsed since it was issued should all be taken into account in this assessment. Where any doubt arises over the quality of the product, it should not be considered suitable for reissue or reuse. Any action taken should be appropriately recorded.

Reagents and Culture Media:

14.34   There should be records for the receipt and preparation of reagents and culture media.

14.35   Reagents made up in the laboratory should be prepared according to written procedures and appropriately labelled. The label should indicate the concentration, standardization factor, shelf-life, the date when re-standardization is due, and the storage conditions. The label should be signed and dated by the person preparing the reagent.

14.36   Both positive and negative controls should be applied to verify the suitability of culture media each time they are prepared and used. The size of the inoculum used in positive controls should be appropriate to the sensitivity required. 

Reference Standards: 

14.37   Whenever official reference standards exist, these should preferably be used. 

14.38   Official reference standards should be used only for the purpose described in the appropriate monograph. 

14.39   Reference standards prepared by the producer should be tested, released and stored in the same way as official standards. They should be kept under the responsibility of a designated person in a secure area. 

14.40   Secondary or working standards may be established by the application of appropriate tests and checks at regular intervals to ensure standardization. 

14.41   Reference standards should be properly labelled with at least the following information: 

(a)   Name of the material; 

(b)   Batch or lot number and control number; 

(c)   Date of preparation; 

(d)   Shelf-life; 

(e)   Potency; 

(f)   Storage conditions. 

14.42   All in-house reference standards should be standardized against an official reference standard, when available, initially and at regular intervals thereafter. 

14.43   All reference standards should be stored and used in a manner that will not adversely affect their quality. Waste materials 

14.44   Provision should be made for the proper and safe storage of waste materials awaiting disposal. Toxic substances and flammable materials should be stored in suitably designed, separate, enclosed cupboards, as required by national legislation.

14.45   Waste material should not be allowed to accumulate. It should be collected in suitable receptacles for removal to collection points outside the buildings and disposed of safely and in a sanitary manner at regular and frequent intervals.


14.46   Rodenticides, insecticides, fumigating agents and sanitizing materials should not be permitted to contaminate equipment, starting materials, packaging materials, in-process materials or finished products.

WHO Good Manufacturing Practices For Pharmaceutical Products: Main Principles

(Annex 2, WHO Technical Report Series 986, 2014)

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