Materials - Starting Materials and Packaging Materials


Materials - Starting Materials and Packaging Materials

14. Materials:

14.1   Principle. The main objective of a pharmaceutical plant is to produce finished products for patients’ use from a combination of materials (starting and packaging).

14.2   Materials include starting materials, packaging materials, gases, solvents, process aids, reagents and labelling materials.


14.3   No materials used for operations such as cleaning, lubrication of equipment and pest control should come into direct contact with the product. Where possible, such materials should be of a suitable grade (e.g. food grade) to minimize health risks.

14.4   All incoming materials and finished products should be quarantined immediately after receipt or processing, until they are released for use or distribution.

14.5   All materials and products should be stored under the appropriate conditions established by the manufacturer, and in an orderly fashion, to permit batch segregation and stock rotation by a first-expire, first-out rule.

14.6   Water used in the manufacture of pharmaceutical products should be suitable for its intended use.

Starting Materials:

14.7   The purchase of starting materials is an important operation that should involve staff who have a particular and thorough knowledge of the products and suppliers.

14.8   Starting materials should be purchased only from approved suppliers and, where possible, directly from the producer. It is also recommended that the specifications established by the manufacturer for the starting materials be discussed with the suppliers. It is beneficial for all critical aspects of the production and control of the starting material in question, including handling, labelling and packaging requirements as well as complaints and rejection procedures, to be contractually agreed between the manufacturer and the supplier.

14.9   For each consignment, at a minimum, the containers should be checked at least for integrity of package and seal and for correspondence between the order, the delivery note, and the supplier’s labels.

14.10   All incoming materials should be checked to ensure that the consignment corresponds to the order. Containers should be cleaned where necessary and labelled, if required, with the prescribed information. Where additional labels are attached to containers, the original information should not be lost.

14.11   Damage to containers and any other problem that might adversely affect the quality of a material should be recorded and reported to the QC department and investigated.

14.12   If one delivery of material is made up of different batches, each batch must be considered as separate for sampling, testing and release.

14.13   Starting materials in the storage area should be appropriately labelled. Labels should bear at least the following information:

(a)   the designated name of the product and the internal code reference where applicable;

(b)   the batch number given by the supplier and, on receipt, the control or batch number given by the manufacturer, if any, documented so as to ensure traceability;

(c)   the status of the contents (e.g. in quarantine, on test, released, rejected, returned, recalled);

(d)   where appropriate, an expiry date or a date beyond which retesting is necessary. When fully validated computerized storage systems are used, not all of the above information need be in a legible form on the label.

14.14   There should be appropriate procedures or measures to ensure the identity of the contents of each container of starting material. Bulk containers from which samples have been drawn should be identified.

14.15   Only starting materials released by the QC department and within their shelf-life should be used.

14.16   Starting materials should be dispensed only by designated persons, following a written procedure, to ensure that the correct materials are accurately weighed or measured into clean and properly labelled containers.

14.17   Each dispensed material and its weight or volume should be independently checked and the check recorded.

14.18   Materials dispensed for each batch of the final product should be kept together and conspicuously labelled as such.

Packaging Materials:

14.19   The purchase, handling and control of primary and printed packaging materials should be as for starting materials.

14.20   Particular attention should be paid to printed packaging materials. They should be stored in secure conditions so as to exclude the possibility of unauthorized access. Roll feed labels should be used wherever possible. Cut labels and other loose printed materials should be stored and transported in separate closed containers so as to avoid mix ups. Packaging materials should be issued for use only by designated personnel following an approved and documented procedure.

14.21   Each delivery or batch of printed or primary packaging material should be given a specific reference number or identification mark.

14.22   Outdated or obsolete primary packaging material or printed packaging material should be destroyed and its disposal recorded.

14.23   All products and packaging materials to be used should be checked on delivery to the packaging department for quantity, identity and conformity with the packaging instructions.

WHO Good Manufacturing Practices For Pharmaceutical Products: Main Principles

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

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