AUDITS IN PHARMACEUTICAL
Mr.Madane Vikram A
Department-pharmaceutical Quality Assurance
Bharati Vidyapeeth College Of pharmacy,
Bharati Vidyapeeth College Of Pharmacy,kolhapur.
Types Of Quality Audits
• Internal Audit
• External Audit
• Regulatory Audit
Role Of Audits In QA&QC Program
Benefits Of Audits
A systematic, independent and documented process for obtaining
evidence and evaluating it objectively to determine the extent to which
criteria are fulfilled.
Quality audit is defined as a systematic and independent examination to
determine whether activities and related results comply with planned
arrangements and whether these arrangements are implemented
effectively and are suitable to achieve objectives
GMP Compliance Audit-
It is the audit related to Good Manufacturing Practice in
Applying to national or international GMP Regulations.
It can be define as an audit conducted by someone external to your
organization with the purpose of discovering GMP deficiencies.
Objective of the Quality Audits-
Pharmaceutical manufacturers commonly use audits as an
effective mechanism to verify compliance with GMP regulation
(GMP).GMP audits with two important goals -
• Audis are intended to verify that manufacturing and Control
systems are operating under a state of control.
• Audits permit timely correction of potential problems.
Audits can be used to establish a High degree of confidence to
remain under an adequate level of control by managements.
To evaluate the manufacturer’s Compliance with GMP in all aspects of production
and Quality control.
Designed to detect any shortcomings in the implementation of GMP and to
recommend the necessary corrective actions.
Performed routinely as well as on special occasions, e.g. in the case of product
recalls or repeated rejections
Items of Self Inspection
Premises including personnel facilities
Maintenance of buildings and equipment
Storage of starting materials and finished
Production and in-process controls
Sanitation and hygiene
Validation and revalidation
Calibration of instruments or
measurement systems Recall
Results of previous self-inspections and
any corrective steps Taken
Types of Quality audits-
The quality audit system mainly classified in three
Staff of section or
A company on its
Internal (First Party) Audits:
A key purpose of an internal audit is hopefully to identify minor
problems and errors before they become a major issue or are discovered
by a third party.
To Ensure that adequate Quality systems are maintained.
To asses compliance with the C-GMP’s and firms standard operating
To achieve consistency between manufacturing and testing facilities.
To identify problems internally and Correct problems prior to a FDA
Designing of the Internal Audit System
In a pharmaceutical facility for internal auditing, you
require to check mainly two things namely –
Activities carried out by different departments.
Documents maintained by these departments.
Implementing the Internal Audit system
Constitute a small Team Of Expert
Provide initial training
Fix Audit Schedule (carried out at least once in a six month)
Report the audit finding and Report given to the top management
and shows corrective action
Repeat the audit as per preplanned Schedule.
External Audit ( 2ndParty):
(A second party audit is one that is carried out by a non-
For example, in some industries, especially pharmaceuticals and
chemicals, customers and potential customers will often ask to visit a company :--
-to ensure they are operating according to a quality system and hence will
provide good quality goods.
Confidence in the partnership arrangement .
Ensuring that requirements are understood .
Enabling reduction of in-house QC testing of starting materials .
Reducing the risk of failure.
Carried Out by a company on its vendors or sub contractors .
No legal requirement for to conduct audit.
Regular audits will be carried out to assesses
compliance with agreed standards .
Confidence in vendor auditing.
Reduce level of external auditing.
External auditors have experience of GMP and as well
as regularly audited by their certification body.
External (Third party Audit) Or
A third party audit is one that is carried out by a
Regulatory auditor or Inspector.
(These are a legal requirement in highly regulated
industries such as pharmaceuticals and food
Purpose of Regulatory Audits.
Networking and confidence-building between national
inspection authorities . Development of quality systems.
Work towards global harmonization of GMP.
Carried out by regulatory bodies such as MCA(U.K), USFDA
(USA)for manufacturing and supply of pharmaceutical
Audits may be unannounced .
Failure of regulatory audit withdrawal of a manufacturing or
After regulatory audit, a formal report will
For MCA :-verbal feedback report is
given at the exit meeting.
For USFDA :-Provides “Form 483”is
given at the exit meeting.
This sort of audit is also a requirement for any company accredited to a
formal quality system such as ISO 9000 or ISO 14000.
ROLE OF GMP AUDITS IN Q.A AND Q.C
What is to be audited-
Employees Practices and behavior.
Compare master specifications against compendia and
regulatory requirements. Verify the test data and validation
Validation test reports are compared against raw data.
Verify Corrective actions taken in reaction to audit finding .
Benefits which are derived from Audits are given as:
1. Assuring GMP compliance.
2. Detecting Potential Problems.
3. Effecting Programmed
4. Increasing management