QAS-012 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 278

SOP No. Val. 100.10 Effective date: mm/dd/yyyy
Approved by:

31.1 PurPose
An internal QA audit system may be defined as a formal program of systematic and comprehensive
self-appraisal by a manufacturer, to ensure consistent and reliable production of quality products
within his operation. The primary purpose of an internal QA audit program is to assist the manage-
ment in identifying and correcting deficiencies before they adversely affect the company's products
and its reputation for quality.
It is important to realize that an internal QA audit program must be dynamic and will undergo
continuing development as sensitivity and awareness to potential problems are increased.

31.2 scoPe
Purchasing, shipping, registration, maintenance, materials planning, stores, QC, R&D, QA, manu-
facturing, and packaging.

31.3 resPonsibility
It is the responsibility of the QA manager to plan and organize an internal QA audit once in a year.
The production director, packaging director, maintenance director, R&D director, QC manager,
production manager, planning manager, stores manager, shipping manager, purchase manager, and
maintenance manager are together responsible to participate or designate in executing a scheduled
inspection of the manufacturing, packaging, stores, maintenance, QC, R&D, and general factory
premises.

Note: During the SOPs audit, the independence of the auditor from the concerned department has
to be maintained.

31.4 Procedure

1. The QA manager will prepare a schedule for audits to cover each department once in a year.

2. During the course of an audit of a section, the officer in-charge or the department head will
be present. For audit, the photocopy of the enclosed checklist will be used as a guideline.

3. The audit team will be composed of the following personnels:

a. QA manager as audit team leader

b. Team member from production

c. Team member from packaging

d. Team member from maintenance

e. Team member from QC

f. Team member from PDL

g. Team member from biotech

4. A report will be issued to the QA director at the end of the audit by the QA manager.

5. This will identify deficiencies and recommend corrective actions to be taken within the
specified frame of time.

6. The manager of each department will be presented with a copy of this report. It will then
be his responsibility to see that corrective actions are taken. The departmental managers
will be responsible for the corrective actions compliance.

7. In presenting any financial justification to the general manager, the departmental managers
should refer to the report of the internal QA audit team.