QUALITY ASSURANCE REPORT (QAR) FORM

Natural Health Products Directorate

HC USE ONLY

Protected when completed

Date/Time of Receipt

Submission Number

File Number

Please refer to the instructions on how to complete this form.

GENERAL INFORMATION
A. Submission
1. Type
2a. Date of last inspection or QAR completion
Site Licence Application
Amendment
Renewal

2b. Type of inspection:

B. Building Information
3. Building Name

4. Building Number (if more than 1 QAR submitted)

of
(one QAR per building)
7. Address (Number/Street/Suite/Land Location)

5. Dwelling House

8. City-Town

11. Country

6. Office

9. Province/State

10. Postal Code/Zip Code

CANADA

C. Operation(s) at this Building

12a.
Add

Non-Sterile Dosage Form

Sterile Dosage Form

Homeopathic Medicine

Manufacturing
Packaging
Labelling
Importing*
(Reduced testing program: Y / N)
Storage only
12b. Supplementary QAR form (for homeopathic medicines only) attached? Yes

No

*Not required for importing activities

13. Dosage Form(s):

(Please consult: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-site-exploit/form/forms_qar_instructions_e.html)
Capsule
Tablet
Pellet
Liquid
Lotion
Extract
Tincture
Powder
Other (specify)

14. Product Type(s):

Plant, alga or fungus
Extracts
Vitamins
Essential fatty acids
Homeopathic medicines

Non-human animal material

Isolates
Minerals
Synthetic duplicates
Traditional medicines

Bacterium
Enzymes
Amino acids
Probiotics

D. Quality Assurance Person(s) (QAP)

15a. Print the Name of Quality Assurance Person (in Section 28 (f)) who completed the QAR for the building listed in
box #3 of this form:

15b.
In-House
Third Party

16a. Print the Name of Quality Assurance Person who is responsible for ensuring that Section 51 of the Natural Health
Products Regulations (approving the materials, methods and procedures; approving product release for sale and resale;
and investigating and recording complaints) is met:

16b.
In-House
Third Party

Page 1 of 27

ATTESTATION
I attest that the building(s), practice(s), and procedure(s) used for conducting activities in our facility comply with the good
manufacturing practices set out in Part 3 of the Natural Health Products Regulations.
Signature of QA Person
Date yyyy-mm-dd
Name of Quality Assurance Person
(Please print)

DETAILED QUALITY ASSURANCE REPORT

PLACES
Premises [Section 45]
(1) Building is designed to prevent cross-contamination and mix-up of the natural
health product(s) by way of:
(a) appropriate space to carry out the operations of the facility;
(b) separated production and non-production areas; and
(c) sealed building surfaces (e.g., windows, floors, ceilings and production surfaces)
made of materials that facilitate maintenance and sanitation.

Yes
Yes
Yes

No
No
No

Yes

No

If yes, describe for (a), (b) and (c) how the premises design complies with NHP GMPs.
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established.
List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail
the corrective action(s) taken and/or to be taken.

Supporting documentation

Page 2 of 27

Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above
(see instructions and records check list for more details).
Attach supporting documentation such as action plans with timelines for each corrective action identified
above.

List of attachments:

Page 3 of 27

Premises [Section 45]

(2) Building is designed to prevent cross-contamination and adulteration of the natural
health product(s) by way of:
(a) adequate ventilation, filtration and airflow;
(b) appropriate plumbing; and
(c) appropriate water supply for the intended purposes (e.g., production, cleaning or
utility functions).

Yes
Yes
Yes

No
No
No

Yes

No

If yes, describe for (a), (b) and (c) how the premises design complies with NHP GMPs.
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established.
List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail
the corrective action(s) taken and/or to be taken.

Supporting documentation
Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above
(see instructions and records check list for more details).
Attach supporting documentation such as action plans with timelines for each corrective action identified
above.

List of attachments:

Page 4 of 27

Premises [Section 45]

(3) Raw material(s) and finished product(s) are stored under conditions that maintain
quality and safety (such as temperature, humidity and light controls).

Yes

No

Yes

No

If yes, describe the conditions and how they are controlled and monitored.
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established.
List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail
the corrective action(s) taken and/or to be taken.

Supporting documentation
Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above
(see instructions and records check list for more details).
Attach supporting documentation such as action plans with timelines for each corrective action identified
above.

List of attachments:

Page 5 of 27

Premises [Section 45]

(4) Building is designed and maintained to prevent the entry and harbouring of insects,
rodents, birds and other animals.

Yes

No

Yes

No

If yes, describe.
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established.
List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail
the corrective action(s) taken and/or to be taken.

Supporting documentation
Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above
(see instructions and records check list for more details).
Attach supporting documentation such as action plans with timelines for each corrective action identified
above.

List of attachments:

Page 6 of 27

Equipment [Section 46]

(5) Equipment is
(a) designed, constructed and maintained to prevent contamination of the natural
health product(s).
(b) functioning in accordance with its intended use through routine maintenance
and calibration.

Yes

No

Yes

No

Yes

No

If yes, describe for (a) and (b) how the equipment complies with NHP GMPs.
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established.
List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail
the corrective action(s) taken and/or to be taken.

Supporting documentation
Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above
(see instructions and records check list for more details).
Attach supporting documentation such as action plans with timelines for each corrective action identified
above.

List of attachments:

Page 7 of 27

PEOPLE
Personnel [Section 47]
(6) In meeting the companys requirements, individuals in charge of manufacturing,
packaging, labelling and/or storage activities have appropriate education, training or
experience, including appropriate initial and ongoing good manufacturing practices
(GMP) training necessary to perform their assigned duties.

Yes

No

If yes, describe how individual(s) meet the requirements to perform their duties relating to the activities, types
of natural health product(s) and dosage form(s).
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established.
List all standard operating procedures (SOPs) (titles and numbers) for this section.

Yes

No

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail
the corrective action(s) taken and/or to be taken.

Supporting documentation
Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above
(see instructions and records check list for more details).
Attach supporting documentation such as action plans with timelines for each corrective action identified
above.

List of attachments:

Page 8 of 27

Quality Assurance [Section 51]

(7) In meeting the companys requirements, the Quality Assurance Person(s) has the
appropriate training, experience and technical knowledge.

Yes

No

If yes, describe how the Quality Assurance person(s) meet the requirements, and has the qualifications to
perform their duties relating to the activities, types of natural health product(s) and dosage form(s).
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established.
List all standard operating procedures (SOPs) (titles and numbers) for this section.

Yes

No

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail
the corrective action(s) taken and/or to be taken.

Supporting documentation
Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above
(see instructions and records check list for more details).
A Quality Assurance Person Qualification Form is required to be completed.
Attach supporting documentation such as action plans with timelines for each corrective action identified
above.

List of attachments:

Page 9 of 27

Quality Assurance [Section 51]

(8) Does this site have a Quality Assurance Person(s) responsible for:
(a) approving the raw, packaging and labelling materials;
(b) methods and procedures;
(c) approving product release for sale and resale; and
(d) investigating and recording complaints

Yes
Yes
Yes
Yes

No
No
No
No

If yes, describe for (a), (b), (c) and (d) how the quality assurance person complies with NHP GMPs.
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established.
List all standard operating procedures (SOPs) (titles and numbers) for this section.
Provide a copy of the SOPs for (1) quality assurance release and (2) complaint handling.

Yes

No

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail
the corrective action(s) taken and/or to be taken.

Supporting documentation
Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above
(see instructions and records check list for more details).
Attach supporting documentation such as action plans with timelines for each corrective action identified
above.

List of attachments:

Page 10 of 27

PROCESSES

Sanitation Program [Section 48]

(9) (a) A sanitation program has been established at the site (whole site/ facility).
(b) Written procedures are established and followed for effectively cleaning the
premises.
(c) Written procedures are established and followed for the cleaning of the
equipment and utensils.

Yes
Yes

No
No

Yes

No

Yes

No

If yes, describe the cleaning procedures including schedules and frequencies.

If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established.
List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail
the corrective action(s) taken and/or to be taken.

Supporting documentation
Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above
(see instructions and records check list for more details).
Attach supporting documentation such as action plans with timelines for each corrective action identified
above.

List of attachments:

Page 11 of 27

Sanitation Program [Section 48]

(10) An employee health and hygiene program has been established at the site to protect
the natural health product(s) against adulteration and contamination.

Yes

No

Yes

No

If yes, describe
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established.
List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail
the corrective action(s) taken and/or to be taken.

Supporting documentation
Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above
(see instructions and records check list for more details).
Attach supporting documentation such as action plans with timelines for each corrective action identified
above.

List of attachments:

Page 12 of 27

Operations [Section 49]

(11) Material control procedures are in place from the receipt to the release of raw, inprocess, packaging, labelling, and reprocessed material(s).

Yes

No

If yes, describe how materials (raw, in-process, packaging and labeling) are quarantined, approved, returned
and designated for disposal.
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established.
List all standard operating procedures (SOPs) (titles and numbers) for this section.

Yes

No

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail
the corrective action(s) taken and/or to be taken.

Supporting documentation
Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above
(see instructions and records check list for more details).
Attach supporting documentation such as action plans with timelines for each corrective action identified
above.

List of attachments:

Page 13 of 27

Operations [Section 49]

(12) Critical process controls are in place, where applicable, at the site for:
(a) manufacturing activities;
(b) packaging activities;
(c) labelling activities;
(d) importing and storage activities.

Yes
Yes
Yes
Yes

No
No
No
No

Yes

No

If yes, describe for (a), (b), (c) and (d) where applicable, the critical process controls.
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established.
List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail
the corrective action(s) taken and/or to be taken.

Supporting documentation
Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above
(see instructions and records check list for more details).
Attach supporting documentation such as action plans with timelines for each corrective action identified
above.

List of attachments:

Page 14 of 27

Operations [Section 49]

(13) A self inspection program against Part 3 of the Natural Health Products Regulations
has been established at the site.

Yes

No

Yes

No

If yes, describe.
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established.
List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail
the corrective action(s) taken and/or to be taken.

Supporting documentation
Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above
(see instructions and records check list for more details).
Attach supporting documentation such as action plans with timelines for each corrective action identified
above.

List of attachments:

Page 15 of 27

Operations [Section 49]

(14) An inspection program has been established for any work contracted out, (e.g.,
contract testing laboratories, domestic suppliers, foreign suppliers, etc.) have been
established.

Yes

No

Yes

No

If yes, describe.
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established.
List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail
the corrective action(s) taken and/or to be taken.

Supporting documentation
Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above
(see instructions and records check list for more details).
Attach supporting documentation such as action plans with timelines for each corrective action identified
above.
List of attachments:

Page 16 of 27

Operations [Sections 50 and 62]

(15) (a) Written procedures are in place at the site to ensure the effective recall of a
product.
(b) Written procedures are in place to ensure that the required information is
submitted to Health Canada (Health Products and Food Branch Inspectorate (HPFBI)
Regional Operational Centre) when a recall is initiated.

Yes

No

Yes

No

Yes

No

If yes, describe.
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established.
List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail
the corrective action(s) taken and/or to be taken.

Supporting documentation
Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above
(see instructions and records check list for more details).
If a product recall has not been done at the site, attach a blank template of the product recall form.
Attach supporting documentation such as action plans with timelines for each corrective action identified
above.
Attach a recall template/ record
List of attachments:

Page 17 of 27

PRODUCT

Specifications [Section 44]

(16) (a) Written procedures are in place and followed to assess finished natural health
products against written specifications.
(b) Written procedures are in place to ensure that any change(s) in specifications are
reflected in the operations and that every change is approved by the quality
assurance person.

Yes

No

Yes

No

(Note: any changes to product specifications require a product licence notification and/or amendment)

If yes, describe and provide evidence for at least two product types manufactured, packaged, labelled and
stored on site.
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established.
List all standard operating procedures (SOPs) (titles and numbers) for this section.

Yes

No

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail
the corrective action(s) taken and/or to be taken.

Supporting documentation
Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above
(see instructions for more details).

Provide certificates of analysis

Attach supporting documentation such as action plans with timelines for each corrective action identified
above.

List of attachments:

Page 18 of 27

Specifications [Section 44]

(17) Written procedures are in place and followed to assess raw and/or packaging
materials against written specifications.

Yes

No

Yes

No

If yes, describe.
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established.
List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail
the corrective action(s) taken and/or to be taken.

Supporting documentation
Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above
(see instructions and records check list for more details).
Provide records of raw material testing if a part of the finished product specifications

Attach supporting documentation such as action plans with timelines for each corrective action identified
above.

List of attachments:

Page 19 of 27

Stability [Section 52]

(18) (a) Data from accelerated or real-time stability studies or from similar product
formulations are used in the initial determination of the expiration date.
(b) An on-going stability program is in place at the site.

Yes

No

Yes

No

If yes, describe how expiry dates are determined and demonstrate that manufactured and/ or imported
products meet their specifications at expiry.
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established.
List all standard operating procedures (SOPs) (titles and numbers) for this section.

Yes

No

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail
the corrective action(s) taken and/or to be taken.

Supporting documentation
Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above
(see instructions and records check list for more details).
Attach supporting documentation such as action plans with timelines for each corrective action identified
above.

List of attachments:

Page 20 of 27

Samples [Section 61]

(19) A sample retention program is in place at the site.

Yes

No

If yes, describe (including information on the duration of retention, environmental conditions, final trade
packages, destruction of samples etc.)
If no, provide a rationale and a copy of a completed Alternate Sample Retention form (http://www.hc-sc.gc.ca/dhpmps/alt_formats/hpfb-dgpsa/pdf/prodnatur/sample_echantillons-eng.pdf)

Standard Operating Procedures

Relevant standard operating procedures are established.
List all standard operating procedures (SOPs) (titles and numbers) for this section.

Yes

No

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail
the corrective action(s) taken and/or to be taken.

Supporting documentation
Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above
(see instructions and records check list for more details).
Attach supporting documentation such as action plans with timelines for each corrective action identified
above.

List of attachments:

Page 21 of 27

Records [Sections 53 to 57]

(20) Required records are maintained as per the Natural Health Products Regulations.

Yes

No

If yes, for all activities conducted at the site, identify in the boxes below where each of the following records are kept.
Use O for records maintained on-site and use A if you have access to the records but they are kept off site.
If no, provide a rationale.
Record

Manufacturer

Packager

Labeller

Importer

Master production document

Manufacturing order
Packaging order
Labelling order
Test results: raw material
Test results: packaging material
Test results: finished product
Specifications: raw material
Specifications: packaging material
Specifications: finished product
Stability summary
Ingredients list
Products list
Distribution list
Complaints
Sanitation program
Other(please specify)
If additional space is required, please attach on a separate sheet.

Standard Operating Procedures

Relevant standard operating procedures are established.
List all standard operating procedures (SOPs) (titles and numbers) for this section.

Yes

No

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail
the corrective action(s) taken and/or to be taken.

Page 22 of 27

Supporting documentation
Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above
(see instructions and records check list for more details).
Attach supporting documentation such as action plans with timelines for each corrective action identified
above.

List of attachments:

Records [Sections 58]

(21) Batch and lot records for the natural health product(s) are maintained as per the
Natural Health Products Regulations.

Yes

No

Yes

No

If yes, describe.
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established.
List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail
the corrective action(s) taken and/or to be taken.

Page 23 of 27

Supporting documentation
Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above
(see instructions and records check list for more details).
Attach supporting documentation such as action plans with timelines for each corrective action identified
above.

List of attachments:

Sterile (e.g. Ophthalmic) Products [Sections 59 and 60]

(22) *All sterile (ophthalmic) products are manufactured and packaged:
(a) in a separate and enclosed area;
(b) under the supervision of personnel trained in microbiology; and
(c) using a method scientifically proven to ensure sterility.

Yes

No

Yes

No

If yes, describe.
If no, provide a rationale.

Standard Operating Procedures

Relevant standard operating procedures are established.
List all standard operating procedures (SOPs) (titles and numbers) for this section.

Deviations and corrective actions

Identify and describe any noted GMP deviation(s) and the rationale for the deviation, where applicable. Detail
the corrective action(s) taken and/or to be taken.

Page 24 of 27

Supporting documentation
Attach a minimum of one photocopy of a completed record(s)/log(s) as outlined in the SOP(s) listed above
(see instructions and records check list for more details).
Attach supporting documentation such as action plans with timelines for each corrective action identified
above.

List of attachments:

*Manufacturers, packagers, labellers, importers and distributors must treat all sterile natural health products in the same manner as any other sterile
health product. Follow the guidance provided in the guidelines posted on Health Canada website.

Page 25 of 27

LIST OF PRODUCTS MANUFACTURED (M), PACKAGED (P), LABELLED (L), IMPORTED (I) AND STORED (S) AT THE SITE

Product Name
(Please attach the
specifications)

Other Brand
Names

Dosage form

Product Type

NPN

Page 26 of 27

PLA #

Storage
conditions
requirements

Shelf Life

M-P-L-I-S

RECORDS CHECK LIST (Please provide samples that have been in use within the last six months)
Questions of
the QAR

Record Type

Check
Box

Relevant sections of
the NHPR

1
2

Building Design
Building Design

45
45

Storage Controls

45

Pest Control

45

46

Equipment Design,
Maintenance and
Calibration
Personnel Training

QAP Qualifications

51(1)(a)

Quality Assurance

51(1)(b),(3),(4)

Premise, Equipment and

Utensils Cleaning

48

10

Employee Health and

Hygiene
Material Control

48

47

*Quality
Technical
Agreement

Example of Acceptable
Record Types
Floor plan
Air filtration, water quality and
system maintenance records
Data logs recording temperature,
humidity, and light controls
Contractor pest control invoice,
internal pest activity inspection
logs
Maintenance and calibration
records (include schedules and
frequencies)
Certificates of data logs (with
trainee signature) of on-going
GMP training (internal or external)
QAPQF, training records,
certificates, job description,
resume, roles and responsibilities
Product release forms, complaint
records, and adverse reaction
reporting records, if any
Data logs of site/facility
Cleaning (production and non
production area) and equipment
cleaning (include
schedules and frequencies)
Hygiene policies, instructions

Certificates of analysis, material

release forms, batch records,
master production documents, out
of specifications investigation
reports
Batch records, master production
12
Process Control
49
documents, out of specifications
investigation reports
Check list or report
13
Self Inspection
49
Check list or report
14
Inspection of Contractors
49
Product recall records
15
Recall
50, 62
Certificate of Analysis, batch
16
Finished Product Testing
44, 51(4)
records of finished products and
raw materials, if applicable.
Certificates of analysis, batch
17
Raw & Packaging material
44, 51(2)
records, material release forms
approval/ release
Data logs from accelerated or
18
Stability
52
real-time stability studies (must
show product meets its label
claim at time of
expiry)
Sample retention record or
19
Sample Retention
61
alternate sample retention form
Evidence of supervisor training in
22
Sterile ophthalmic NHPs
59, 60
microbiology, clean room/ laminar
flow hood maintenance records,
product sterilization records,
batch records
*Please provide copies of signed and dated quality technical agreements along with the relevant record samples as evidence.

11

49

Page 27 of 27