GMP, QC and QA

What is quality assurance (QA)?

A wide-ranging concept which covers all matter which influence the quality of a product.

What is good manufacturing practice (GMP)?

A part of QA which ensures products meet quality standards appropriate to their intended use.

What is quality control (QC)?

A part of GMP which is concerned with sampling, specifications and testing. Products cannot be released until their quality has been judged to be satisfactory.

What are the elements of QA?

- General procedures.

- Training, all staff are trained.

- Validation, processes will do reproducibly.

What are the elements of GMP?

- Following the correct procedures.

- Training

- Documentation.

- Audit of processes

What are the elements of QC?

- Analytical testing of raw materials

- Analytical testing of finished products

- Comparison against specifications.

-Batch release..

What is required for each operation/process?

An SOP

What are SOPs?

A set of instructions which must always be:

- Followed

- Clear and ordered logically.

- Easy to understand.

- Reviewed regularly and approved by an appropriate person.

What is raw material specifications?

The necessary chemical and physical properties of a raw material.

What is finished product specification?

The necessary chemical and physical properties of a finished product.

What must specifications be?

- Clear and unambiguous.

- Reviewed regularly.

- Approved by an appropriate person.

What are the types of documentation?

- Specifications

- SOPs

- Records

- Batch manufacturing documents

What is an analytical test record?

The in-detail results of all tests on a product. States who did the work and whether the batch complies with relevant specifications.

What is a cleaning record?

A record of equipments that has been cleaned before being used. States who did the cleaning and who approved that the cleaning is done and that the equipment is fit for use.

What is a training record?

A record of the staff that have been trained. States who did the training and the 'level of achivement' of the individual.

What is a use and maintenance record?

A record of the use of a piece of equipment and who used it. States what its used for and any maintenance or repair of the equipment.

What is a receipt record?

A record of where and when a product was purchased and how much of it was recieved.

What is a dispatch record?

A record of when and where a product was sent to and how much was sent.

What is a reconciliation record?

A record of how much product is available and is related to receipt and dispatch records.

What is batch manufacturing documents?

A unique summary of how each batch was manufactured. Must be filled in immediately and by the staff performing that process.

What must batch manufacturing documents be?

- Clear and unambiguous.

- Ordered logically.

- Approved by an appropriate person.