Packaging control Good Manufacturing Practice

The explicit control of named contaminants requires that the possibility of their presence has been recognised and recorded in, for example, a negative list. Almost by definition, the majority of contaminants are not of this nature. Analysis for contaminants in packaging materials and for any migration of same, is difficult and almost open-ended. For this reason, much emphasis is needed on Good Manufacturing Practice and in record-keeping. 

Ensure that facilities listed in the new drug applications (NDA) have the capabilities to fulfill the commitments to manufacture, process, control, package, and label a drug product following good manufacturing practices (cGMPs). 

Establishment of good quality control techniques and good manufacturing practices and of facilities for formulation and packaging development activity to undertake compatibility and stability tests as well as safety testing and bioavailability studies. 

Before any efforts are made to reduce contamination, knowledge of the materials, the processes by which they are made, the packaging materials in which they may be packed, how such packs may be opened, removed/unscrambled, etc., are an essential part of total control. Basically these are all part of good manufacturing practice (GMP). However, before this can be done some agreement must be reached on what constitutes contamination and how it may be detected. 

The aspects of quality assurance which deal with production and quality control are dealt with in the guidelines provided for this purpose under the term GMP (Good Manufacturing Practice). Production is the department in charge of the manufacture and packaging of products according to the effective basic documents. This includes the series of operations from the collection of the necessary starting materials to the delivery of the end product as well as control of the conditions under which these activities take place. 

Good Manufacturing Practice and Quality Control of Human Medications and Means of Medical and Packaging Technology... 

In batch-oriented quality management systems, such as good manufacturing practice (GMP), the batch number of an active substance or a product is the main index variable, where the entire information about sourcing of materials, manufacturing, analysis (control), packaging, and distribution is attached. 

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