INSPECTION REPORT FOR NON BIOLOGICALS

(Each page must be signed by the inspectors.

Inspection Checklist shall be filled separately for each premises).
Part I
Manufacturer Inspected:__________________________________________________________
______________________________________________________________________________
Inspection Date:________________________________________________________________
Inspectors: 1.__________________________________________________________________
2.__________________________________________________________________
References (Mfg Licence; date of issue)
______________________________________________________________________________
Inspection Scope________________________________________________________________
Part II
A. Quality System
1. Change Control
i). Documented Yes / No
ii). Properly evaluated Yes / No
iii). Approved Yes / No
2. Is there any product improvement project Yes / No
3. Product review
i). Annually Yes / No
ii). Batch reviewed Yes / No
iii). Identification of trends Yes / No
4. Complaint review
i). Quality and Medical Yes / No
ii). Documented Yes / No
iii). Evaluated Yes / No
iv). Investigated in timely manner Yes / No
v). Corrective action taken Yes / No
5. Returns
i). Documented Yes / No
ii). Evaluation Yes / No
1 / 21
 iii). Corrective action taken Yes / No
6. Rejects
i). Investigation expanded where warranted Yes / No
ii). Corrective action where appropriate Yes / No
7. Stability failure
i). Investigation where warranted Yes / No
8. Quarantine products Yes / No
9. Validation
i). Computers Yes / No
ii). Manufacturing process Yes / No
iii). Laboratory Methods Yes / No
10. Training / qualification Yes / No
i).
ii).
iii).
iv).
11. Follow up of National Control Authority’s inspection and recommendations
Yes / No
12. Inspection system for contractors Yes / No
13. Frequency of environmental monitoring Yes / No
14. Mechanism of self inspection Yes / No
15. Adequate Water Processing Facility Yes / No

Good / Weak Points

_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________

B. Facility and equipment system

I). Facilities
1). Cleaning and maintenance Yes / No

2 / 21
2). Facility layout and air handling systems for prevention of cross-contamination (e.g.
penicillin, beta-lactams, steroids, hormones, cytotoxics,etc.). Yes / No
3).specifically designed areas for the manufacturing operation performed by the firm to
prevent contamination or mix-ups Yes / No
4). General air handling systems Yes / No

A) HVAC – System

i. Are pre-filters present in heating, ventilation and air- conditioning (HVAC)

Systems and replaced on a routine basis? Yes / No
ii. Are HEPA filters terminally located? Yes / No
iii. Are duct works and filters located out side the clean rooms? Yes / No
iv. If fumigation procedures are used, does the facility design permit effective
fumigation? Yes / No
v. Is the air flow adequate in all areas of production building? Yes / No
vi. Are room temperature and humidity effectively controlled? Yes / No

B) COMPRESSED AIR

i. Is the air supply pass through filters in the sterile area? Yes / No
ii. Are the air compressors properly maintained? Yes / No

C) CLEAN STEAM

i. Is clean steam used for sterilization processes during manufacturing

operations? Yes / No

5). Control system for implementing changes in the building Yes / No

6). Lighting, potable water, washing and toilet facilities, sewage and refuse disposal
Yes / No
7). Sanitation of the building, Yes / No
8). Use of rodenticides, fungicides, insecticides Yes / No
9). Use of cleaning and sanitizing agents Yes / No

3 / 21
 10). Dis inspection SOP / Record Yes / No
11).Piping system, valves, vent filter Yes / No

Good / Weak Points

_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________

II). Equipment
1). Appropriate equipment installation Yes / No
2). Appropriate operational qualification. Yes / No
3). Adequacy of equipment design, size, and location Yes / No
4). Equipment surfaces are not reactive, additive, or absorptive Yes / No
5). Appropriate use of equipment operations substances, (lubricants, coolants, refrigerants,
etc.) contacting products / containers / etc. Yes / No
6) Cleaning procedures with proper documentation Yes / No
7). Cleaning validation Yes / No
8). Controls to prevent contamination, particularly with any pesticides or any other toxic
materials, or other drug or non-drug chemicals Yes / No
9). Qualification, calibration and maintenance of storage equipment,
i). Refrigerators and freezers for ensuring that standards Yes / No
ii). Raw materials Yes / No
iii). Reagents, etc Yes / No
10). Equipment qualification, calibration and maintenance, including computer
qualification / validation and security Yes / No
11). Control system for implementing changes in the equipment Yes / No
12). Equipment identification practices (where appropriate) Yes / No
13). Documented investigation into any unexpected discrepancy Yes / No
14). Written SOP available and followed

Good / Weak Points

4 / 21
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
C. Material System
1). Training / qualification of personnel Yes / No

2). Identification of
i). Components, Yes / No
ii). Containers, Yes / No
iii). Closures Yes / No
3). Inventory of
i). Components, Yes / No
ii). Containers, Yes / No
iii). Closures Yes / No
4). Storage conditions Yes / No
5). Storage under quarantine until tested or examined and released Yes / No
6). Representative samples collected, tested or examined using appropriate means
Yes / No
7). At least one specific identity test is conducted on each lot of each component
Yes / No
8). A visual identification is conducted on each lot of containers and closures Yes / No
9). Testing or validation of supplier’s test results for
i). Components, Yes / No
ii). Containers, Yes / No
iii). Closures Yes / No
10). Rejection of following not meeting acceptance requirements. (Investigate fully the
firm’s procedures for verification of the source of components) Yes / No
i). Components, Yes / No
ii). Containers, Yes / No
iii). Closures Yes / No
11). Appropriate retesting / reexamination of
i). Components, Yes / No

5 / 21
 ii). Containers, Yes / No
iii). Closures Yes / No
12). First in first out use of
i). Components, Yes / No
ii). Containers, Yes / No
iii). Closures Yes / No
13). Quarantine of rejected materials Yes / No
14). Water and process gas supply, design, maintenance, validation and operation
Yes / No
15). Containers and closures are not additive, reactive, or absorptive to the drug product
(documentary report is available) Yes / No
16). Control system for implementing changes in the materials handling operations
Yes / No

17). Qualification / validation and security of computerized or automated processes

Yes / No
18). Finished product distribution records by lot Yes / No
19). Documented investigation into any unexpected discrepancy Yes / No

Good / Weak Points

_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
D. Production system
1. Tablet Section
a). Equipment installed
i)_______________________ ii)______________________iii)_____________________
iv)______________________ v)______________________vi)_____________________
vii)_____________________ viii)_____________________ix)_____________________
b). Documentation
i). Receipt of material Yes / No
ii). In process (weighing , mixing, granulation, compression) Yes / No

6 / 21
 iii). IPQC Yes / No
c). Validation of processes
Process Date of Validation Validated by
i). ________________ ________________ ___________________
ii). ________________ ________________ ___________________
iii). ________________ ________________ ___________________
iv). ________________ ________________ ___________________
v). ________________ ________________ ___________________
vi). ________________ ________________ ___________________
d). Calibration data of
Instrument Date of Calibration Calibration by
i). ________________ ________________ ___________________
ii). ________________ ________________ ___________________
iii). ________________ ________________ ___________________
iv). ________________ ________________ ___________________
v). ________________ ________________ ___________________
vi). ________________ ________________ ___________________
e). Professionals supervision
Name Qualification Signature
i). ________________ ________________ ___________________
ii). ________________ ________________ ___________________
iii). ________________ ________________ ___________________
iv). ________________ ________________ ___________________
v). ________________ ________________ ___________________
vi). ________________ ________________ ___________________

7 / 21
2. Injectable Section
a). Equipment installed
i)_______________________ ii)______________________iii)_____________________
iv)______________________ v)______________________vi)_____________________
vii)_____________________ viii)_____________________ix)_____________________
b). Documentation
i). Receipt of material Yes / No
ii). In process (weighing, mixing, clarity, leakage) Yes / No
iii). IPQC Yes / No
iv). Microbiology of air Yes / No
v). Maintenance of positive pressure Yes / No
vi). Maintenance of aseptic area Yes / No
vii). Maintenance of Animal House Yes / No
viii). Facility of Endotoxin / Pyrogen Testing Yes / No
c). Sterile Processing
i). Are the aseptic manufacturing areas and operations consistent with the WHO
guidelines for sterile biological products. Yes / No
ii). Does the aseptic manufacturing area include : Yes / No
iii). Smooth, hard non-particulate generating clean-able floors, walls and ceiling? Able to
withstand cleaning, disinfecting reagents? Yes / No
iv). No horizontal pipes or conduits located over exposed components, in-process
material, production or product contact surfaces? Yes / No
v). Environmental controls, e.g. temperature, humidity and viable and non-viable
particles? Are their specifications for these controls? Has the system been validated?
Yes / No
vi). Air supply through HEPA filters? Yes / No
vii). Fixtures (electrical outlets and lighting, etc.) flush mounted and sealed to prevent air
leakage, water access? Yes / No
viii). Identification of all pipes or conduits for air, clean steam or liquids? Yes / No
ix). Properly equipped gowning area/air-lock? Yes / No

x). The ability to achieve appropriate air standards (Grade A,B,C, & D) during operation?

8 / 21
 Yes / No
xi). The ability to maintain the appropriate pressure differentials between work areas with
different grades of air? Yes / No
xii). Dose the aseptic manufacturing area exclude: Yes / No
xiii). Access doors for servicing equipment and fixture? Yes / No
(should only be from outside area).
xiv). Drain? Yes / No
xv). Sinks? Yes / No

d) Water For Injection (WFI) System

i). Is the design of the WFI system adequate to supply sufficient water of
(Pharmacopoieal) quality? Yes / No
ii). Is there a holding tank for the WFI system? Yes / No

e). Validation of processes

Process Date of Validation Validated by
i). ________________ ________________ ___________________
ii). ________________ ________________ ___________________
iii). ________________ ________________ ___________________
iv). ________________ ________________ ___________________
v). ________________ ________________ ___________________
vi). ________________ ________________ ___________________
d). Calibration data of
Instrument Date of Calibration Calibration by
i). ________________ ________________ ___________________
ii). ________________ ________________ ___________________
iii). ________________ ________________ ___________________
iv). ________________ ________________ ___________________
v). ________________ ________________ ___________________
vi). ________________ ________________ ___________________
e). Professionals supervision
Name Qualification Signature
9 / 21
 i). ________________ ________________ ___________________
ii). ________________ ________________ ___________________
iii). ________________ ________________ ___________________
iv). ________________ ________________ ___________________
v). ________________ ________________ ___________________
vi). ________________ ________________ ___________________

3. Capsule Section
a). Equipment installed
i)_______________________ ii)______________________iii)_____________________
iv)______________________ v)______________________vi)_____________________
vii)_____________________ viii)_____________________ix)_____________________
b). Documentation
i). Receipt of material Yes / No
ii). In process (weighing , mixing) Yes / No
iii). IPQC Yes / No

c). Validation of processes

Process Date of Validation Validated by
i). ________________ ________________ ___________________
ii). ________________ ________________ ___________________
iii). ________________ ________________ ___________________
iv). ________________ ________________ ___________________
v). ________________ ________________ ___________________
vi). ________________ ________________ ___________________

d). Calibration data of

Instrument Date of Calibration Calibration by
i). ________________ ________________ ___________________
ii). ________________ ________________ ___________________
iii). ________________ ________________ ___________________
iv). ________________ ________________ ___________________

10 / 21
 v). ________________ ________________ ___________________
vi). ________________ ________________ ___________________

e). Professionals supervision

Name Qualification Signature
i). ________________ ________________ ___________________
ii). ________________ ________________ ___________________
iii). ________________ ________________ ___________________
iv). ________________ ________________ ___________________
v). ________________ ________________ ___________________
vi). ________________ ________________ ___________________

4. Syrup / Suspension Section

a). Equipment installed
i)_______________________ ii)______________________iii)_____________________
iv)______________________ v)______________________vi)_____________________
vii)_____________________ viii)_____________________ix)_____________________
b). Documentation
i). Receipt of material Yes / No
ii). In process (weighing , mixing) Yes / No
iii). IPQC Yes / No
iv). Filling / Packing Yes / No

c). Validation of processes

Process Date of Validation Validated by
i). ________________ ________________ ___________________
ii). ________________ ________________ ___________________
iii). ________________ ________________ ___________________
iv). ________________ ________________ ___________________
v). ________________ ________________ ___________________
vi). ________________ ________________ ___________________

11 / 21
 d). Calibration data of
Instrument Date of Calibration Calibration by
i). ________________ ________________ ___________________
ii). ________________ ________________ ___________________
iii). ________________ ________________ ___________________
iv). ________________ ________________ ___________________
v). ________________ ________________ ___________________
vi). ________________ ________________ ___________________
e). Professionals supervision
Name Qualification Signature
i). ________________ ________________ ___________________
ii). ________________ ________________ ___________________
iii). ________________ ________________ ___________________
iv). ________________ ________________ ___________________
v). ________________ ________________ ___________________
vi). ________________ ________________ ___________________
5. Ointments / Creams Section
a). Equipment installed
i)_______________________ ii)______________________iii)_____________________
iv)______________________ v)______________________vi)_____________________
vii)_____________________ viii)_____________________ix)_____________________

b). Documentation
i). Receipt of material Yes / No
ii). In process (weighing , mixing) Yes / No
iii). IPQC Yes / No
iv). Filling / Packing Yes / No

c). Validation of processes

Process Date of Validation Validated by
i). ________________ ________________ ___________________
ii). ________________ ________________ ___________________

12 / 21
 iii). ________________ ________________ ___________________
iv). ________________ ________________ ___________________
v). ________________ ________________ ___________________
vi). ________________ ________________ ___________________

d). Calibration data of

Instrument Date of Calibration Calibration by
i). ________________ ________________ ___________________
ii). ________________ ________________ ___________________
iii). ________________ ________________ ___________________
iv). ________________ ________________ ___________________
v). ________________ ________________ ___________________
vi). ________________ ________________ ___________________

e). Professionals supervision

Name Qualification Signature
i). ________________ ________________ ___________________
ii). ________________ ________________ ___________________
iii). ________________ ________________ ___________________
iv). ________________ ________________ ___________________
v). ________________ ________________ ___________________
vi). ________________ ________________ ___________________

II) General
1). Training / qualification of personnel Yes / No
2). Control system for implementing changes in processes Yes / No
3). Adequate procedure and practice for charge-in of components Yes / No
4). Formulation / manufacturing at not less than 100% Yes / No
5). Identification of equipment with contents, and where appropriate phase of manufacturing
and / or status Yes / No
6). Calculation and documentation of actual yields and percentage of theoretical yields

13 / 21
 Yes / No
7). Contemporaneous and complete batch production documentation Yes / No
8). Implementation and documentation of in-process controls, tests, and examinations (e.g., pH,
adequacy of mix, weight variation, clarity) Yes / No
9). Justification and consistency of in-process specifications and drug product final specifications
Yes / No
10). Prevention of objectionable microorganisms in non-sterile drug products Yes / No
11). Adherence to preprocessing procedures (e.g., set-up, line clearance, etc.) Yes / No
13). Equipment cleaning and use logs Yes / No
14). Master production and control records Yes / No
15). Bath production and control records Yes / No
16). Process validation, including validation and security of computerized or automated processes
Yes / No
17). Change control; the need for revalidation evaluated Yes / No
18). Documented investigation into any unexpected discrepancy Yes / No

III) Good / Weak Points

_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
E. Packaging and labeling system
I) Specific
a). Equipment installed
i)_______________________ ii)______________________iii)_____________________
iv)______________________ v)______________________vi)_____________________
vii)_____________________ viii)_____________________ix)_____________________
b). Documentation
i). Receipt of material Yes / No
ii). In process Yes / No
iii). IPQC Yes / No
iv). Packing Yes / No

14 / 21
 c). Validation of processes
Process date of validation validated by
i). ________________ ________________ ___________________
ii). ________________ ________________ ___________________
iii). ________________ ________________ ___________________
iv). ________________ ________________ ___________________
v). ________________ ________________ ___________________
vi). ________________ ________________ ___________________

d). Calibration data of

Instrument date of validation validated by
i). ________________ ________________ ___________________
ii). ________________ ________________ ___________________
iii). ________________ ________________ ___________________
iv). ________________ ________________ ___________________
v). ________________ ________________ ___________________
vi). ________________ ________________ ___________________

e). Professionals supervision

Name Qualification Signature
i). ________________ ________________ ___________________
ii). ________________ ________________ ___________________
iii). ________________ ________________ ___________________
iv). ________________ ________________ ___________________
v). ________________ ________________ ___________________
vi). ________________ ________________ ___________________
II) General
1. Training / qualification of personnel Yes / No
2. Acceptance operations for packaging and labeling materials Yes / No
3. Control system for implementing changes in packaging and labeling operations Yes / No
4. Adequate storage for labels and labeling, both approved and returned after issued Yes / No
5. Control of labels which are similar in size, shape, and color for different products Yes / No

15 / 21
 6. Finished product cut labels for immediate on containers which are similar in appearance
without some type of 100 percent electronic or visual verification system or the use of dedicated
lines Yes / No
7. Gang printing of labels is not done, unless they are differentiated by size, shape, or color
Yes / No
8. Adequate packaging records that will include specimens of all labels used Yes / No
9. Control of issuance of labeling, examination of issued labels and reconciliation of used labels
Yes / No
10. Examination of the labeled finished product Yes / No
11. Adequate inspection (proofing) of incoming labeling Yes / No
12. Use of lot numbers, destruction of excess labeling bearing lot /control numbers Yes / No
13. Physical / spatial separation between different labeling and packaging lines Yes / No
14. Monitoring of printing devices associated with manufacturing lines. Yes / No
15. Line clearance, inspection and documentation Yes / No
16. Adequate expiration dates on the label Yes / No
17. Conformance to tamper-evident (TEP) packaging requirements Yes / No
18. Validation of packaging and labeling operation including validation and security of
computerized processes Yes / No
19. Documented investigation into any unexpected discrepancy Yes / No

III) Good / Weak Points

_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________

F. Laboratory control system

I) Specific
a). Equipment installed
i)_______________________ ii)______________________iii)_____________________
iv)______________________ v)______________________vi)_____________________
vii)_____________________ viii)_____________________ix)_____________________
c). Validation of processes

16 / 21
 Process date of validation validated by
i). ________________ ________________ ___________________
ii). ________________ ________________ ___________________
iii). ________________ ________________ ___________________
iv). ________________ ________________ ___________________
v). ________________ ________________ ___________________
vi). ________________ ________________ ___________________
d). Calibration data of
Instrument date of validation validated by
i). ________________ ________________ ___________________
ii). ________________ ________________ ___________________
iii). ________________ ________________ ___________________
iv). ________________ ________________ ___________________
v). ________________ ________________ ___________________
vi). ________________ ________________ ___________________
e). Professionals supervision
Name Qualification Signature
i). ________________ ________________ ___________________
ii). ________________ ________________ ___________________
iii). ________________ ________________ ___________________
iv). ________________ ________________ ___________________
v). ________________ ________________ ___________________
vi). ________________ ________________ ___________________

II) General
1. Training / qualification of personnel Yes / No
2. Adequacy of staffing for laboratory operations Yes / No
3. Adequacy of equipment and facility for intended use Yes / No
4. Calibration and maintenance programs for analytical instruments and equipment
Yes / No
5. Validation and security of computerized or automated processes Yes / No

17 / 21
 6. Reference standards; source, purity and assay, and tests to establish equivalency to current
official reference standards as appropriate Yes / No
7. System suitability checks on chromatographic systems (e.g., GC or HPLC) Yes / No
8. Specifications, standards, and representative sampling plans Yes / No
9. Adherence to the written methods of analysis Yes / No
10. Validation / verification of analytical methods Yes / No
11. Control system for implementing changes in laboratory operations Yes / No
12. Required testing is performed on the correct samples Yes / No
13. Documented investigation into any unexpected discrepancy Yes / No
14. Complete analytical records from all tests and summaries of results Yes / No
15. Quality and retention of raw data (e.g., chromatograms and spectra) Yes / No
16. Correlation of result summaries to raw data; presence of unused data Yes / No
17. Adherence to an adequate Out of Specification (OOS) procedure which includes timely
completion of the investigation Yes / No
18. Adequate reserve samples; documentation of reserve sample examination Yes / No
19. Stability testing program, including demonstration of stability indicating capability of the test
methods. Yes / No
20. Reference Books available Yes / No

III) Good / Weak Points

_________________________________________________________________________________

_________________________________________________________________________________

_________________________________________________________________________________

Part-III

1) Location of Firm in Factory Area

2) Premises
a) Total Area covered ________________

b) Total investment___________________

3) Products

18 / 21
a) Total Registered __________________________

b) In-process of manufacturing____________________

i)________________________ii)_____________________iii)_________________

iv)_______________________v)_____________________vi)__________________

c) Products applied for registration in Pakistan are on Free Sale in the country of origin

d) Brand Name Generic Name Invoice No. Date

i) ____________ ____________ _____________ __________

ii) ____________ ____________ _____________ __________

iii) ____________ ____________ _____________ __________

iv) ____________ ____________ _____________ __________

v) ____________ ____________ _____________ __________

vi) ____________ ____________ _____________ __________

vii) ____________ ____________ _____________ __________

viii) ____________ ____________ _____________ __________

ix) ____________ ____________ _____________ __________

xi) ____________ ____________ _____________ __________

xii) ____________ ____________ _____________ __________

Signature of Production Manager/Plant Manager__________________________

4) Personnel

a) Health Status Monitoring Yes / No

b) Personal Hygiene Yes / No

c) Job description available Yes / No

d) Organizational Chart Yes / No

e) Responsibility of Key Persons Yes / No

19 / 21
f) Number of Total Pharmacists_______________________________________

g). Number of total Chemists__________________________________________

h). Number of other technical Staff______________________________________

i). Name of Plant Manger_____________________ Signature______________

j). Name of Prod. Manager______________________ Signature______________

5) Certification of Sole Agency Certificate

It is certified that M/s.________________________________________________ has only

declared / authorized M/s._________________________________________ as their sole agent in

Pakistan for the following products.

01.___________________________________ 02. ___________________________________

03..___________________________________ 04. ___________________________________

05.___________________________________ 06. ___________________________________

07.___________________________________ 08. ___________________________________

09.___________________________________ 10. ___________________________________

11.___________________________________ 12. ___________________________________

Signature of representative of the firm_________________________________________

Name _________________________ Designation______________________________

GENERAL REMARKS

20 / 21
Over All Evaluation Of The Inspection Report

Rating Very Good

Good

Satisfactory / Average

Un Satisfactory

FINAL REMARKS:

RECOMMENDED/ NOT-RECOMMENDED

Name/Signature of Inspector i) ______________________________________________

ii) ________________________________________________

4. Comments of the firm’s representative

_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_____________________________________________________________________

Signature of the firm’s representative.

21 / 21