Types of Audit in Pharmaceutical industry

There are basically 3 types of quality audits in pharmaceutical industries.

 

-Internal audits

-External audits

-Regulatory audits

Internal audits:

-Internal audits are carried out by an organization on its own system, procedures and facilities.

-Internal audits are also required for business perspective.

-Procedure and programme of internal audit should be available

-One possible system for internal audit is a three-tier approach.

-It may be categorize in following way:

Tier-one audits

Tier-two audits

Tier-three audits

Tier-one audits:

-Carried out by the staff of a section or dept themselves.

-Audit will typically be short and focusing on visible such as housekeeping and documentation.

-For this, Auditors are usually selected on the basis of knowledge and experience of area to be audited, though they should also receive some basic training.

Tier-two audits:

-Typically carried out by a local QA group comprising staff independent of the dept unit.

-Such audits will typically be longer but less frequent and are likely to focus on system than housekeeping.

-More exclusive training will be required for tier two auditors with more detail on quality system and techniques.

Tier-three audits:

-Carried out by corporate compliance group.

-Alternatively external consultant may be used.

-Such audits are often carried out to assess readiness for regulatory audit but may also be used to have an expert view on specific critical activity.

-Tier-three auditors are likely to be highly trained and experienced or specialist with an expert knowledge of GMP and other regulatory requirements for pharmaceuticals.

External audits:

-External audits are carried out by a company on its vendors or subcontractors .

-There is no legal requirement to conduct such audits.

-Need of such audit is implicit since manufacturers are required to have though knowledge of their suppliers.

-Furthermore if work is contracted out they must ensure that contractor are competent to complete it in accordance with GMP.

-There are also strong business benefits of performing these audits:

-Building knowledge and confidence in the partnership arrangements

-Ensuring that requirements are understood and met

-Enabling reduction of certain activities

-Reducing the risk of dangers

-External auditors typically have a broad practical experience of GMP and receive quality systems auditing systems training equivalent to that of ISO 9001 lead auditors.

-Audit system may also include specific training experts.

-Many pharmaceutical industry suppliers are ISO 9001 certified their certification bodies.

Regulatory audits:

-These audits are carried out by regulatory bodies against relevant systems for manufacture and supply of pharmaceutical products.

-National regulatory bodies such as medicine control agency (MCA) in the UK and and FDA in USA are statutorily responsible for carrying out such audits.

-These audits may be unannounced (e.g. MCA currently performs about 10% of its UK performance like this)

-Regulatory bodies from other countries in which products are sold may also audit companies.i.e. FDA audits European manufacturers.

-Regulatory inspectors are extensively trained and they are knowledgeable. All MCA inspectors are relatively qualified and have minimum of 5 yrs experience in manufacturing operations.

-Currently different regulatory bodies have distinct audit stages and requirements but to reduce cost and audit burden on manufacturers. They have been moved towards sharing and mutually recognizing audits.