International Standards Certifications

SYSTEM AUDIT PLAN

Company : Magna Laboratories (Gujarat) Pvt. Ltd.,

9:00 a.m. 4th November 2000

Address :

N. Bhattacharya-Lead Auditor.
Shankar Ghosh Auditor.
P.J.Shah Technical Expert
Mr. Ravi Bandurge- LA (Auditor) H.O
5:30 p.m. 5th November 2000

Opening
Meeting:
H.O.:- 5/6, Shreyas, 2nd Hasnabad Lane, Audit Team:
Santacruz(w), Mumbai-400 054. India.
Site:- Plot No. 712, J Road, 40 Shed
Area, G.I.D.C., Vapi- 395 195.

Auditors
Conference:
Exit Meeting:

6:00 p.m. 5th November 2000

System Audit Scope:

Manufacturing and Marketing of Pharmaceutical Products for Domestic and

Export Market.
Date(s): 4th & 5th November 2000
Clause

4.11
4.12

QUALITY SYSTEM REQUIREMENT

ISO 9002 - 1994
Management Responsibility
Quality System/Procedure review
Contract Review
Design Control
Document and Data Control
Purchasing
Control of Customer Supplied Product
Product Identification and Traceability
Process Control
Inspection and Testing
- Receipt
- In process
- Final
Control of Inspection, Measuring and Test Equipment
Inspection and Test Status

4.13

Control of Non-conforming Product

4.14
4.15
4.16

Corrective and Preventive Action

Handling, Storage, Packaging, Preservation and Delivery
Control of Quality Records

4.17
4.18
4.19

Control of Internal Quality Audits

Training
Servicing

4.20

Statistical Techniques

4.1
4.2
4.3
4.4
4.5
4.6
4.7
4.8
4.9
4.10

Department/Sections to be audited:

AudPln 01
Issue 1 Rev 0

Management
Marketing (HO)
Production
Quality Assurance
Maintenance

AUDITORS
NB + PS
4th a.m.
4th a.m.
4th a.m.
4th p.m.
4th p.m.

SG
4th a.m.
4th a.m.
4th a.m.
th
5 p.m.
4th p.m.
4th p.m.

RB
th
4 a.m.
4th p.m.
-

5th a.m.

5th a.m.
4 p.m./5 th
a.m.
4th p.m./ 5th
a.m.
th
5 p.m.
4th /5th a.m./
p.m.
4th a.m.
-

5th a.m.
4th / 5th
a.m. / p.m.
4th a.m.
-

4th a.m./
p.m.
-

5th p.m.

4th a.m.

th

Management Representative
Purchase (HO)
Quality Control
Technical Services
Safety / Factory Management

International Standards Certifications (South Asia) Pvt. Ltd.

Telephone: + 91 079 6567518
Fax: + 91 079 6567518
FAX TO
ATTN
FAX NO
FROM
SUBJECT
DATE
No of Pages

:
:
:
:
:
:
:

Magna Laboratories (Gujarat) Pvt. Ltd.

Mr. Sachin Gandhi, Managing Director
022 - 6491424
N. Bhattacharya
Audit Plan- Initial Audit
31st October 2000
2

Dear Mr. Sachin Gandhi,

We wish to confirm the details of the Magna Laboratories (Gujarat) Pvt. Ltd., - Mumbai / Vapi,
Company Quality System Initial Audit planned for the 4th & 5th November 2000 . The purpose of
the audit is to verify compliance of your Quality Manual, associated procedures and practices to
the requirements of ISO 9002-1994.
Our audit team will comprise of N. Bhattacharya-Lead Auditor, Shankar Ghosh Auditor, P.J.Shah
Technical Expert, Ravi Bandurge Auditor. The Audit will commence with an Entry Meeting as
per the attached program included for your information.
We would bring to your attention at this time that you have the right to object to any of the
proposed audit team members. Should you have any objections to any of the audit team members
please let us know and we would be pleased to discuss this confidentially in order to resolve the
matter satisfactorily.
It would be appreciated if you could arrange for management personnel to be available to attend
both Entry and Exit Meetings.
It is our intention that the audit should be conducted with the minimum of disruption to your
normal work program, and it would therefore be appreciated if you could arrange for a
knowledgeable person to be available to accompany the auditor during the audit. Easy access to
pertinent manuals and procedures should be made available to the audit team during the audit.
We confirm that during our audit we would require access to an office, telephone and
photocopying facilities.
Should you have any queries with regard to the arrangements for this audit, please do not hesitate
to contact the undersigned.
Yours sincerely,

N. Bhattacharya.
Lead Auditor