International Standards Certifications Pvt Ltd

Report No

A.C.N. 071 810 949

The Quality Centre, 14 Telopea Avenue, Homebush West, NSW 2140, Australia

Page No.
Audit Date(s)

A/91/ 094
1 of 6
99/03/15 to 99/03/16

PRELIMINARY AUDIT REPORT

COMPANY:

AUDITED
SITE(S):
STANDARD:
CLIENT:

ALEMBIC CHEMICAL WORKS CO. LTD.

Alembic Road, Vadodara 390 003.
ISO 9002-1994

As above
SCOPE OF AUDIT / CAPABILITY

Manufacturing and Marketing of Bulk Drug and Formulation for Domestic and International Market.
ISC observations/comments made during the Preliminary Audit of Alembic Chemical Works Co. Ltd.,
Vadodara on 15th & 16th of March99 by N. Bhattacharya and Mr. Bipin Rajadhyaksha, Lead Auditors
enclosed in this report.

Reported ByN. Bhattacharya.SignatureDate..17/03/99.

FORM 5 AUDREP 1
ISSUE 1
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PAGE 1 OF 6

ALEMBIC CHELICAL WORKS CO. LTD.

PRELIMINARY AUDIT REPORT
BY: N. Bhattacharya

4.1

Report No
Page No.
Audit Date(s)

A/91/ 094
2 of 6
99/03/15 to 99/03/16

MANAGEMENT RESPONSIBILITY:

Procedure no. COM/XXX/P/03 Rev-0, the responsibility of the Departmental Heads to be specified.
Procedure No. COM/XXX/P/04 Rev.0. The responsibility lies with M.R. where as the Co-ordinator
assisting him is signing in his absence. There is no provision made in the Quality system to justify the
same.
M.R. was appointed by the Sr. V.P. on 24.9.98, where as none of the management review was done by
any management personal having Executive responsibility. The Management reviews are conducted by
M.R. on monthly basis. Therefore the requirement laid down in ISO under clause no. 4.1.3 is not
fulfilled in the Organization.
Procedure No. COM/XXX/P/07 Rev-0 the responsibility of implementing the procedure is shown as
M.R. and concerned HOD. This is to be made clear indicating the areas of responsibilities.
The Organizational chart has not been provided with the names of the persons responsible for different functions.

4.2

QUALITY SYSTEM:

QRD/QAD/P/02, Procedure for approval of BMR, the next step to be taken if found error by the QC during checking has not
been mentioned.
DOC No. MKT/DOM/P/01 to be Reviewed (planning). All planning procedures are made in a isolated manner these are to be
integrated and to be documented as being done actually. The involvement of MIS Function, Steering Committee/Executive
Committee for Annual planning needs to be more clearly spelled out in procedure.
Written down procedure and actual activity being carried for customer complain is not same. The procedure in actual practice
is better than what is written.
There is no working procedure for the working of Drug Liaison Manager.

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ALEMBIC CHEMICAL WORKS CO. LTD.

PRELIMINARY AUDIT REPORT
BY: N. Bhattacharya
4.3

Report No
Page No.
Audit Date(s)

A/91/ 904
3 of 6
99/03/15 to 99/03/16

CONTRACT REVIEW:

ISO

Clause No. 4.3.2 i.e. contract review made it a requirement to review the suppliers capability to
meet the contract requirement. In the marketing export department there is no formal system available to
substantiate the same.
In the marketing bulk drug department few such information in a informal way was available in the
personal Dairy of HOD marketing.
4.4.

DESIGN CONTROL

Not Applicable
4.5

DOCUMENTS AND DATA CONTROL:

Internal Audit Intimation format has no document No.

The Format used on 2/01/99 and 30/12/98 for internal audit intimation are not same. There is no
revision/Amendment also available.
DOC No. COM/XXX/F/04/03 with out date is kept in the internal Audit file for Jan99 was signed by
person other than M.R. where as per procedure M.R. is the authorized person.
DOC No. MKT/EXP/F/01/03 dtd 11/01/99 is referring to Inquiry No. HE/ALEM/99/ dated 11.01.99 was
not available in the file.
Monthly projection dated. 6/3/99 refers to Target March99, where as this was not available in the file
ACW/Exp/05 of Marketing Export Department.
Doc No. PDN/F-2/R/04/01 was changed by unauthorized person in Liquid Oral Department.
In the ETP department Daily analysis report is not being signed by the HOD even though there is a
provision in the format for signature.
DOC PDN/F-1/G/01 lists upto PDN/F-1/P/16 whereas Document Distribution list indicates upto PDN/F1/P/17.
SOP Numbers linking to ISO9002 documentation nos. as records link to SOP Nos. only. Procedures to
ISO 9002 Nos.
Document No. 08 Master Process Record has not been approved and authorized. These are critical Process Parameters.

Doc. No. QCD/F1/F/02/04 of 4/3/99 gives chemical analysis of Penicillin but not reviewed for
specification and cleared for further procession.
FORM 5 AUDREP 1
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ALEMBIC CHEMICAL WORKS CO. LTD.

PRELIMINARY AUDIT REPORT
BY: N. Bhattacharya

Report No
Page No.
Audit Date(s)

A/91/ 094
4 of 6
99/03/15 to 99/03/16

Document No. 08 Master Process Record has not been approved and authorized. These are critical Process Parameters.

Doc. No. QCD/F1/F/02/04 of 4/3/99 gives chemical analysis of Penicillin but not reviewed for
specification and cleared for further processing.
4.6

PURCHASING:

Sub Contractor monitoring procedure yet to be implemented.

No master list of sub contractor was found available with the Instrumentation Head of Factory 2 for the
out side calibration being got done by him.
4.7

CONTROL OF CUSTOMER SUPPLIED PRODUCT :

Not Applicable
4.8

PRODUCT IDENTIFICATION AND TRACEABILITY:

Found Satisfactory
4.9

PROCESS CONTROL:

The accidents are not being recorded in Safety Department. It is proposed to introduce an accident
Register for recording all Accident Investigation Report.
There was no yearly maintenance plan available for effective Maintenance of equipment at cogeneration department.
House keeping of fermentation shop floor needs improvement.
Electric Cables of fermentation section of Factory 1, identification and tracing may be looked into.
4.10

INSPECTION & TESTING:

Sampling plans are not standardized as per IS2500 also no statistical basis for the sampling plan being followed is
available.
4.11

CONTROL OF INSPECTION MEASURING AND TEST EQUIPMENT:

Calibration procedure is silent about instrument which are out of calibration.

In the Calibration Master list there is no column available for acceptance level of inaccuracy of a
particular instrument at particular location consistent with the process requirement. Addressing this
would be help full to enhance the instrument life, also to monitor process more accurately.

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Report No

ALEMBIC CHEMICAL WORKS CO. LTD.

Page No.

PRELIMINARY AUDIT REPORT

BY: N. Bhattacharya

Audit Date(s)

A/91/ 094
5 of 6
99/03/15 to 99/03/16

No calibration details was found on the balance no. W.I. in the Tablet department sub store.
Calibration procedure is silent about instrument which are out of calibration.
Pressure Gauges Calibration system has not been defined.
Rotometer Sanitary type for KPG addition is used for controlling critical parameter but not identified
and included in calibration schedule .
4.12

INSPECTION AND TEST STATUS:

Format No. QRD/QCD/F/02/04 for Microbial count Report, there is no provision for Accepting or
rejecting the results by the HOD QC Lab.
4.13

CONTROL OF NON-CONFORMING PRODUCTS:

Found to be satisfactory.
4.14

CORRECTIVE AND PREVENTIVE ACTION:

Found to be satisfactory
4.15

HANDLING, STORAGE, PACKING, PRESERVATION AND DELIVERY:

Item Code FPP 1 Dos as per Stock Statement dated. 15/3/99. should be 90 boxes in finished good store. Whereas only 30
boxes were found during audit and no issue could be traced.
As per procedure No. STR/FGS/P/02 the Sr. Supervisor is responsible for dispatch of finished goods. To avoid errors as above
it would be a good practice to Review the same by any other function also before the final dispatch taken plan.
Pineapple Flavor items code 2013 against TR No. 897298 found 19 litres in actual stock, whereas as per stock record the
quantity available was 12.420 litres.
Identification of stores to be made more specific to avoid wrong issues in packaging material store.

4.16

CONTROL OF QUALITY RECORDS:

Internal Audit Plan has not been covered under list Quality record.
Subject wise Training needs were identified on a paper with out any document/file reference with out any
date, more over there was no signature available to identify the person responsible for the job.
There is no formal procedure to save the quality records of purchase function which are on computer. This needs to be
addressed indicating the authority responsible to take backup, interval for doing so, Identification of such records and also
preservation to avoid damage of quality records.
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ALEMBIC CHEMICAL WORKS CO. LTD.

PRELIMINARY AUDIT REPORT
BY: N. Bhattacharya

Report No
Page No.
Audit Date(s)

A/91/ 094
6 of 6
99/03/15 to 99/03/16

In Store (Raw Material) Test report No. 891919 against Clarithromycin was not found available in the
file with GRN. The filling system of the TR to be Reviewed.
Test report No. 890733 dtd. 26/07/98 issued by the QCRM was not been signed in place of Analyzed
by.
4.17

INTERNAL QUALITY AUDIT:

Internal Audit report No. SI/F2E/DCP/01 dated. 09/01/99, the Audit location has not been mentioned.
The follow up Audit comments are not referring to the actual corrective action taken, no objective evidence was available in
the reports.
4.18

TRAINING

Doc No. COM/XXX/F/08/06 dated. 19.2.99 was found available with Training Coordinator signed by
Mr. P. D. Rawal but none has approved the same till date.
Training feed back forms are received. But there is no clear cut system/Procedure available to summarize and put up to
appropriate Authority to take suitable decision on the effectiveness of the Training being conducted by the Organization.

It would be a good practice to look into the effectiveness of the Training program being conducted by the
Organization by monitoring the trainees performance after training by the same authority who has
identified and recommended for the training.
No Training on ISO was given to the people working with the Drug liaison department.
4.19

SERVICING:

Not Applicable
4.20

STATISTICAL TECHNIQUES:

Found to be complying.
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