Standard Operating Procedures.

To ensure that quality is built-in to the product at every stage of manufacture, it is required by all pharmaceutical and medical device regulators, that all processes used throughout the manufacturing, testing, calibrating and maintaining activities executed in the production of goods, must be documented. These documents must follow a company approved format and be reviewed and approved prior to use. IQ and OQ SOP's are part of the generic documents that are already for sale on this site in their respective places. Other SOP's will be produced as separate documents. Other SOP's are being prepared right now.

The cGMP Review is undertaken to ensure that a design and/or facility conforms to the cGMP requirements and is fit for purpose. The requirement for Regulatory Compliance will be established during the proposal preparation.
cGMP Reviews should normally take place in accordance with the project programme. The initial cGMP Review should take place immediately after the project initiation, to define the cGMP Envelope and clarify the cGMP requirements. Additional cGMP reviews should be held towards the end of the front end design and detailed design.
It is good housekeeping practice for department heads to instigate periodic cGMP walk rounds to analyse, document and ascertain if everyday wear and tear to the fabric of the facility, is compromising the validated status of the facility.

The ever sought after SOP for writing an SOP. Adopting a standard format throughout a company for the easy authoring of SOP's is of immense benefit to everyone that has to use them. Our format follows our standard company developed format of a generic template prefixed by an SOP. Follow the SOP and you quickly and simply produce a sound compliant SOP document. In this case the generic SOP template is prefixed by a SOP, follow the SOP and you complete your SOP. Sound confusing ! not really, just nice, easy and quick to use.

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