QC Profile

Quality control, or QC

Inspection is a major component of quality control, where physical product is examined visually (or the end results of a service are analyzed). Product inspectors will be provided with lists and descriptions of unacceptable product defects such as cracks or surface blemishes for example

The quality of the outputs is at risk if any of these three aspects is deficient in any way.

Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a manufactured product is safe for human consumption or use. Many countries have legislated that manufacturers follow GMP procedures and create their own GMP guidelines that correspond with their legislation.

All guideline follows a few basic principles

• Manufacturing facilities maintain a clean and hygienic manufacturing area.

• Manufacturing facilities maintain controlled environmental conditions in order to prevent cross-contamination from adulterants and allergens that may render the product unsafe for human consumption or use.

• Manufacturing processes be clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.

• Manufacturing processes be controlled, and any changes to the process must be evaluated. Changes that affect the quality of the drug are validated as necessary.

• Instructions and procedures be written in clear and unambiguous language using good documentation practices.

• Operators be trained to carry out and document procedures.

• Records be made, manually or electronically, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the food or drug was as expected. Deviations be investigated and documented.

• Records of manufacture (including distribution) that enable the complete history of a batch to be traced be retained in a comprehensible and accessible form.

• Any distribution of products minimize any risk to their quality.

• A system be in place for recalling any batch from sale or supply.

• Complaints about marketed products be examined, the causes of quality defects be investigated, and appropriate measures be taken with respect to the defective products and to prevent recurrence.

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