All incoming materials should be checked to ensure that the consignment corresponds to the order.

Damage to containers is not GMP target due to not categorized as material. Therefore, only storage control is applied

Intermediate and bulk products purchased as such should not be handled on receipt as though they were starting materials.

At the critical process, products and materials should be protected from microbial and other contamination

If the labels applied to containers, equipment or premises is clear, it’s not necessary to use the specific format

If a deviation from instructions and procedures occur, it should be discarded even has been approved by competent person

Access to production premises should be restricted to authorized personnel

Normally, the production of medicinal products is not allowed in areas and with the equipment destine for the non-medicinal products. However, the production of non-medicinal products in areas and with the equipment destine for the medicinal products is accepted

Providing appropriate air locks and air extraction is one of the appropriate technical measures to avoid cross contamination

Using “open systems” of production is one of the appropriate technical measures to avoid cross contamination

Any minor amendments to the manufacturing process, including any changes in equipment or materials, which may affect product quality and/or the reproducibility of the process should be validated

Processes and procedures should undergo periodic critical revalidation to ensure that they remain capable of achieving the intended results.

The purchase of starting materials is an important operation which should involve only QA staff who have a particular and thorough knowledge of the suppliers

Starting materials should only be purchased from approved suppliers named in the relevant specification

The deviation less than the expected yield should be recorded and investigated

The purchase, handling, and control of all packaging materials, not limited to primary and printed packaging materials, should also be accorded attention similar to that given to starting materials

Each delivery or batch of all materials should be given a specific reference number or identification mark

The line-clearance can be performed to the items that are not being described on the check list

The name and batch number of the product being handled should be displayed at each packaging station or line

Samples taken away from the packaging line should not be returned.

The reprocessing of rejected products should be exceptional.

Finished product assessment is only compatible with finished product specification

Any quality control documentation relating to a batch record should be retained for one year after the expiry date of the batch

Validation for analytical methods of pharmacopoeia listing is not required.

Laboratory reagents intended for prolonged use should be marked with the preparation date and the signature of the person who prepared them. The expiry date of unstable reagents and culture media should be indicated on the label, together with specific storage conditions.