Materials product packaging

Regulatory authorities inspect GMP facilities to ensure compliance to GMP. The FDA carries out surveillance and compliance inspections. A system-based approach is adopted quality, facilities and equipment, materials, production, packaging and labeling, and laboratory control. Deficiencies are reported on Form FDA-483, which may lead to a warning letter and consent decree if unresolved. 

Manufacture All operations of receipt of materials, production, packaging, repackaging, labeling, re-labeling, quality control, release, storage, and distribution of APIs and related controls. 

Set of Specifications A collection of the various specifications and requirements concerning a product, a piece of equipment or a service which is submitted by a customer to a supplier. Specifications Monographs defining the characteristics with which raw materials, products, packaging materials, etc. must comply. 

Suck, A.H., Chewing Gum History and Development, Raw Materials, Production. Packaging, Haarmann Reimer, Holtzminden, Germany, 1988, p. 60. 

Considering the relative barrier and inertness properties of packaging materials, how will these factors affect the shelf life of the product packaged in it ... 

Therefore, the use of mineral oil-reduced RCP grades, e.g. free of newspapers, for food packaging will lead of course to a reduction of the mineral oil contamination and in consequence of the migration problem into foodstuff. However, in general, there will still exist a permanent input of mineral oil from the packaging material production not intended to be used for non-food packaging. The mineral... 

Aerosol products Packaging, propellants, final product assay Raw materials screening Quality control Gas mixture analysis... 

Specifications are normally written by QC personnel. They detail the exact qualitative and quantitative requirements to which individual raw materials or product must conform. For example, specifications for chemical raw materials will set strict criteria relating to the percentage active ingredients present, permitted levels of named contaminants, etc. Specifications for packing materials will, for example, lay down exact dimensions of product packaging cartons specifications for product labels will detail label dimensions and exact details of label text, etc. Specifications for all raw materials are sent to raw material suppliers and, upon their delivery, QC personnel will ensure that these raw materials meet their specifications before being released to production (the raw materials are held in quarantine prior to their approval). Final product specifications will also be prepared. As most products are manufactured to conform with pharmacopoeial requirements, many of the specifications set for raw materials/finished product are simply transcribed from the appropriate pharmacopoeia. 

The basic structure of the ICH GMP guideline for API production is shown in Table 15. It consists of 19 chapters, which cover the requirements for quahty management, personnel, premises, equipment, documentation, materials, production and process controls, packaging and labeling, storage and distribution, laboratory controls, validation, change control, complaints, recalls, contract services, cooperators, APIs manufactured by cell culture/fermentation, and APIs used in clinical trials [52]. 

The manufacture of pharmaceutical ingredients must be protected from contamination beginning with the charging of raw materials through packaging the excipient into the market container. Generally contamination arises from two sources exposure of the excipient to the environment during the production process and flaws in the equipment. 

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