Winthrox laboratories (Pvt.

)
Ltd Regulatory Department

Checklist of Quality Control SI/21/QC/03

Corrective &
Sr. No. Check Points Yes / No Remarks Timeline
Preventive Actions
General :
1. Does   each     section have    Yes/No
relevant      standard operating
procedures [SOPs]?
1.0 Does Quality Assurance Yes/No
Department assures the quality of
all the batches manufactured, at
every stage of manufacturing/
processing of drug products?
2.0 Is this achieved by performing the Yes/No
functions of monitoring as per the
laid down QA systems for the
following areas:
2. Warehousing of incoming Yes/No
components, containers and
closures, labels etc
3. Manufacturing process and process Yes/No
checks
4. process validation, Process Yes/No
monitoring and Process controls.
5. Production Record Review Yes/No
6. Final release or rejection of every Yes/No
batch of Drug Products for
distribution and sale
7. Stability testing and evaluation of Yes/No
shelf-life of products

8. Warehousing of finished products Yes/No

(Drug Products)
Complaints and product recalls Yes/No
9. Handling of Change Control Yes/No
Systems
10. Out of specification investigations Yes/No
 Winthrox laboratories (Pvt.)
11. Regulatory Department
Ltd

Checklist of Quality Control SI/21/QC/03

Investigation of deviations Yes/No

12. Returned products (salvage and Yes/No
disposal)
13. Internal Quality Audits and Quality Yes/No
Review
14. Control of non-conforming Yes/No
products
15. Reprocessing of non-conforming Yes/No
products
3.0 To achieve the objectives of Yes/No
Quality Assurance, Does the
functions of the department can be
classified as follows?
16. To plan and manage all the Yes/No
activities of the Quality Assurance
to assure the quality of all products
manufactured by the Company.
17. To coordinate with the Yes/No
manufacturing department in
controlling their process and
products at every stage of
manufacturing to meet the
established specifications through
testing, auditing and reporting.
18. To co-ordinate for development of Yes/No
specifications, the analytical
procedure in coordination with the
Quality Control and R&D.
19. To review the adequacy and Yes/No
relevance of specifications &
analytical procedures in
coordination with the Quality
Control and R&D.
20. To co-ordinate technical audits of  Yes/No
the Quality Control Laboratory to
determine the analytical Quality
Systems are yielding the highest
quality information and to ensure
that the analytical instrumentation
 Winthrox laboratories (Pvt.)
Ltd Regulatory Department

Checklist of Quality Control SI/21/QC/03

is functioning properly and

calibration and servicing is as per
schedule.
21. To be responsible for the Quality Yes/No
Assurance and records and release
functions of the QA Department
which shall include:
a. Maintenance of Quality Control Yes/No
records of manufacturing
procedures for each batch
manufactured.
b. Records of release, quarantine or Yes/No
rejection of components and
finished products, containers,
closures and labels based on
Quality Control
test results.
c. Routine “Good Manufacturing Yes/No
Practices Auditing” of the
manufacturing process, control and
related areas.
3.0 To achieve the objectives of Yes/No
Quality Assurance, Does the
functions of the department can be
classified as follows?
22 To plan and manage all the Yes/No
activities of the Quality Assurance
to assure the quality of all products
manufactured by the Company.
To suggest and organize training Yes/No
programmes for the development
of technical and administrative
4.0 skills of all the employees to meet
with cGMP regulations on a
continuous basis, which co-
coordinating with Plant and Quality
Head.
To establish guidelines and Yes/No
procedures on cGMP and Good
 Winthrox laboratories (Pvt.)
5.0 Regulatory Department
Ltd

Checklist of Quality Control SI/21/QC/03

Laboratory Practice – Standard

Operating Procedures of overall
Quality Control & Assurance
Activities. Protocols related to
Method / Process/ Cleaning/
Analytical Method Validation etc.
To assist Change Control Yes/No
Committee/Technical Committee
for overall reviews of non-
6.0 conformances, failure
investigations, analyzing the
Quality trends, investigations of
market complaints, batch failure
investigations, deviations,
verifications of change control
procedures, updating the
specifications, test procedures,
manufacturing processes etc.
To liaison with regulatory Yes/No
7.0 authorities for new products
manufacturing licenses and
renewals of the same and other
regulatory requirements.
To follow the reporting system to Yes/No
8.0 the Corporate Quality Head on
daily/ weekly/ monthly basis as per
the standard procedure. (Reporting
System)
28 Dose QA issues BMR and BPR Yes/No

29 Dose QA issues GTIN and Yes/No

maintain record
30 Rentention sample handling,storage Yes/No
and record keeping.
31 Logbook issuance and checking on Yes/No
daily basis and as and when
required.
32 Dose QA perform APR Yes/No

33 Dose QA perform Risk Yes/No

 Winthrox laboratories (Pvt.)
Ltd Regulatory Department

Checklist of Quality Control SI/21/QC/03

Management

34 Does QA perform cleaning Yes/No

validation, Area Validation
35 Does QA perform Area Validation Yes/No

36 Does QA perform CAPA Yes/No