Management System Certification

Stage 1 Audit Report

Organization:

Ray Pharma (Pvt) Limited

Address:

B-52, SITE, Hawksbay road Karachi, Pakistan.

Standard(s):

ISO 9001:2008 & ISO 14001:2004

Representative:

Miss Rizwana Waseem (Management representative / Manager Quality)

Site(s) audited:

01

EAC Code:

13

Accreditation Body(s): UKAS

Date(s) of audit(s):

NACE Code:

24.4

25/10/2012

Technical
Area code:

13.1 for QMS

15 for EMS

Effective No.of
Personnel:

15

No. of Shifts:

01

Lead auditor:

Annus Uddin Khan

Additional team
member(s):

Muhammad Arif Laiq

This report is confidential and distribution is limited to the audit team, client representative and the
SGS office.

1. Audit objectives
The objectives of this audit were:


to confirm that the management system has been planned to conform with all the requirements of the
audit standard;


to confirm that the management system is designed to achieve the organizations policy objectives;


to evaluate the ability of the management system to ensure compliance with statutory, regulatory and
contractual requirements;


Note: A management system certification audit is not a legal compliance audit


to obtain pertinent information to provide for stage 2 audit effectiveness and planning, evaluation of the
clients location and site specific conditions, collection of information related to the processes and
operations within the scope of the management system and identification of key performance or
significant aspects and objectives.


to evaluate the state of readiness of the management system for the stage 2 audit, including an
evaluation of internal audit and management review planning and performance and a determination of
the overall level of implementation of the management system;


to confirm the planned arrangements and resources for the Stage 2 audit.


to provide feedback to the organization to facilitate continual improvement.

2. Audit scope
Marketing and Manufacturing of Pharmaceuticals comprising of sterile and non sterile products in oral and
parental dosage form.
For multi-site audits an Appendix listing all relevant sites and/or remote
locations has been established (attached) and agreed with the client

Job n: PK12678
CONFIDENTIAL

Report date: 25-10-2012

Document: GS0303

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3. Critical audit findings

The following findings, if not appropriately addressed, could result in major nonconformities being identified
at the Stage 2 audit.
QMS:
In the Job description (RP-JD-01) some old formats of JDsof laboratory staff found with different
authorizing authorities.
In raw material storage area and material dispensing area, the temperature guage of refrigerator
and hygrometer installed in different locations found not calibrated.
In compression machines QA in-process release cards, no date was specified.
In coating room, a hole was found in the junction of DI water line and tap water line. Cervixes found
along with the hood of coater and ceiling.
In the packing room, a weighing scale was found without calibration tag.
In the microbiological media preparation room, an open drain was found.
EMS:

Few of the discrepancies were observed in Environmental aspect / impact studies: e.g.Methodology
for the actions required against Likelihood and Magnitude are not defined. Moreover, studies for
Storage areas, Workshop, solvent room, Pakcging area and Waste yard etc are also required to
carried out.

Waste management needs focus on overall locations, i.e. identification, segregation and storage
with regards to hazardous and non hazardous was not identified at waste collection points in
production areas and at junk yard. Moreover, tracking for the disposal in environmental friendly
manner is also required for hazardous waste generating from different activities.

4. Non critical audit findings

The following findings, if not appropriately addressed, could lead to weaknesses being identified at the Stage
2 audit.
QMS:
In the product flow diagram, sequences of product realisation stages not specified.
At the entrance of production area, the insectacutor found not working.
In packaging material store, some loose packaging material were found and some cartons were torn
for example IBSA MR.
In mixing/granulation department, backside parts of ribbon mixer found rusty.
In Sterile ampule filling area, an unshielded energy savor was found in the filling area (class 100)
In the packing department, dust and threads were found in the duct outlet.
EMS:

In few of the locations, spill control and secondary containment arrangements found missed e.g.
Ethyl olate cans in store and diesel storage tank etc. In raw material storage area, refrigerator
condensate and diesel found spilled on the floor.

Legal compliance register is not developed. Similarly the status of applicable requirements is not
maintained.

In Emergency preparedness and response procedure RP-SP/F-14, frequency for the emergency
drills are also required to mentioned.

Job n: PK12678
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Report date: 25-10-2012

Document: GS0303

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In Management review meeting procedure RP-SP/F-01, few of the environmental agenda points are
not defined e.g. communications from external parties, Status of EMS objectives and legal
compliance etc.

MSDS needs to be placed for the chemicals and solvents at their storage areas.

Few of the fire fighting equipments found out of order e.g. at solvent storage room

Drain plan for the overall facility needs to be developed.

Results of Environmental monitoring plan will be verified in stage 2 audit.

Internal audit and Management review meetings are planned and their evaluation will be done in
Stage 2 audit.

5. Audit Conclusions
The Stage 1 audit was successful in meeting the stated objectives:

Yes

No

The stage 1 audit was limited in time and scope to the stated objectives and it is possible that additional
weaknesses will be identified during future audit activities. With consideration to the findings identified in section
3 and 4 of this report, the overall conclusions of the audit are as follow:
The management system has been planned to conform with all the requirements of
Yes
No
the audit standard:
The management system is designed to achieve the organizations policy objectives:

Yes

No

Based on the information provided, the system is designed to identify and manage
compliance with statutory, regulatory and contractual requirements:

Yes

No

The internal audit and management review planning assure appropriate coverage prior
to the Stage 2 Audit:

Yes

No

Yes

No

Yes

No

Any scope exclusions are appropriate and justified:

N/A

The Stage 2 audit should proceed as presently planned:

Comments or details of necessary changes to the stage 2 audit plan:

Please note that all the findings listed in the Critical and Non-critical areas above, are required to be
addressed / closed out before going for the stage-2 audit. Also it is worth mentioning here that the
results of the Stage-2 audit will be independent of the Stage-1 audit results.

6. Opening and Closing Meeting Attendance Record

Name

Position

Opening

Closing

Mr. Tamim Ahmed

Director production

Yes

Yes

Miss Rizwana Waseem

Manager Quality

Yes

Yes

Job n: PK12678
CONFIDENTIAL

Report date: 25-10-2012

Document: GS0303

Visit Type: Stage 1

Issue n:
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