Instructions for Completing the Summary of Net Changes Form

Please read the instructions prior to completing this application.

Parts 1 through 5 must be completed for each Canadian and Foreign sites listed on the Renewal Summary Report.

PART 1: COMPANY INFORMATION

Name of Company: The legal name of the applicant or company as it appears on the site licence.

PART 2: ATTESTATION

To be completed by the Quality Assurance Person of the company.

PART 3: LIST OF OBSERVATIONS AND CORRECTIVE ACTIONS with DATE OF COMPLETION (If applicable)

Please refer to your last site licence cover letter for list of observations noted by the Natural Health Products Directorate (NHPD), if applicable. Applicant to address any observations noted by the NHPD and describe the corrective action(s) taken.

PART 4: SUMMARY OF NET CHANGES and DESCRIPTION

Applicant to identify changes which have occurred since the last issuance or renewal of the site licence by checking the appropriate box(es). In addition, please provide a detailed description of the change(s) by completing the corresponding questions of the Quality Assurance Report (QAR) and Supplementary Quality Assurance Report (SQAR), if applicable, and attach to this form. To obtain the QAR or the SQAR, please refer to http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/ licen-site-exploit/form/form_qar-raq-eng.php

For example: Changes to equipment would be described in the response to questions 5 to 7 of the QAR and corresponding page(s) would be attached to the summary of net changes form.

PART 5: RECORDS SECTION

Applicants to provide copies of all records indicated in this Section for each site listed in the Renewal Summary Report. These records must have been in use within the last six months.

Please note that the record types required depending on the activities performed are specified in the table below.

Records 1-8	Domestic Manufacturers, Packagers, Labellers and Importers
Records 1-4	Domestic Storage Sites/Warehouses
Records 1-8	Foreign Manufacturers, Packagers, Labellers
Records 1-4	Foreign Storage Sites/Warehouses

Contracting: In cases where a contractual arrangement exists for the manufacturing, packaging, labeling, importing, and /or storage of natural health products, the above requirements with respect to records remain applicable. In addition, the applicant must provide a copy of the quality technical agreement in question (signed and dated by the parties involved), indicating the name and address of each party and which parties are conducting the activities for which requirements with respect to GMP are outlined under Part 3 of the Natural Health Products Regulations (NHPR). The licensed status of each party involved in the Agreement (whether they hold a site or establishment licence) should be indicated as well.

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SITE LICENCE RENEWAL - SUMMARY OF NET CHANGES FORM
Natural Health Products Directorate

Please refer to the attached Instructions for Completing the Summary of Net Changes Form before completing this application.

PART 1 - SITE INFORMATION
Name of Company/Licensee:
Site Licence Number:
Building Name:
Building Address:
PART 2 - ATTESTATION
"I hereby attest that I have knowledge of the information provided in this application for site licence renewal and that the information supplied at the time of application, previous renewal or amendment with respect to the sites listed on the site licence are still correct". (No changes to good manufacturing practice information provided in previous evidence e.g .Quality Assurance Report (QAR), Third Party Audit Reports etc for all sites, except for those identified under Part 4.)
Name of Quality Assurance Person:			Signature:			Date: y y y y | m m | d d
PART 3 - LIST OF OBSERVATIONS WITH CORRECTIVE ACTIONS with DATE OF COMPLETION PART 3 - (If applicable)
Observations	Corrective Action Taken			Date of completion
PART 4 - SUMMARY OF NET CHANGES and DESCRIPTION (please identify type of change by checking the appropriate box(es) in the table below and submitting the corresponding question(s), complete with detailed description of change(s), from the Quality Assurance Report Form), if applicable.
There have been no changes to the information supplied at the time of the previous application. (If checked, please proceed to Part 5) GMP Categories GMP Sub Categories Sections of NHPR* QAR** Questions SQAR*** Questions Places Premises 45 1-4 1 Equipment 46 5-7 - People Personnel 47 8-9 2 Quality Assurance 51 10-11 - Processes Sanitation Program 48 12-13 3 Operations 49 & 50 14-18 4-7 Products Specifications 44 19-21 8 Stability 52 22-23 9 Samples 61 24 - Records 53-58 25-26 - Recall Reporting 62 27 - Sterile Products 59 & 60 28 - *NHPR - Natural Health Products Regulations; **QAR - Quality Assurance Report; ***SQAR - Supplementary Quality Assurance Report; - Not Applicable Please refer to Part 4 of the instructions for completing the Summary of Net Changes Form (attached) in order to provide a description of the identified changes.
PART 5 - RECORDS SECTION (Please provide samples that have been in use within the last six months)
Record	Check Box	Record Type	Relevant Section(s) of Part 3 of NHPR	Instructions	Detailed Instructions	Example of Acceptable Record Types
1		Storage Controls	45(2)	Supply records demonstrating that natural health products are stored under conditions that maintain quality and safety.	N/A	Data logs recording temperature, humidity, and light controls
2		Pest Control	45(d,e)	Supply records demonstrating that natural health products are manufactured, packaged, labeled and stored in premises that are maintained in a manner that prevents the contamination of the products.	N/A	Contractor pest control invoice, internal pest activity inspections logs
3		Personnel Training	47	Supply records demonstrating that natural health products are manufactured, packaged, labeled and stored by personnel that are qualified by education, training or experience to perform there respective tasks.	N/A	Certificates or data logs (with trainee signature) of on-going Good Manufacturing Practices (GMP) training (internal or external)
4		Sanitation	46(a), 48	Supply records demonstrating that natural health products are manufactured, packaged, labeled and stored with a sanitation program.	N/A	Data logs of site/facility cleaning and equipment cleaning (include schedules and frequencies)
5		Finished Product Testing	44(1,2), 51(4)	Supply records demonstrating that every natural health product complies with its specifications with respect to medicinal ingredients, identity, quantity and potency if applicable, and product purity. Note: Supply records of raw material testing only if it is part of the finished product specifications.	If more than 1 product type is handled by your site, supply records of full testing for 2 separate product types (e.g. herbal supplement and vitamin). Note: Importers may employ a reduced testing program. See section 1.4.1 of the Good Manufacturing Practices guidance document for specific requirements.	Certificate of Analysis, Batch Records of finished products and raw materials, if applicable.
6		Quality Assurance and Product Release	51	Supply records demonstrating that every lot or batch of natural health product has been approved by a quality assurance person before being made available for sale.	N/A	Standard Operating Procedure(s) Finished Product Release record or Release Certificate
7		Product recall Procedure	50, 62	Supply records demonstrating that the manufacturer, packager, labeller and/or importer have an established system of control that permits the rapid and complete recall of every lot or batch of the natural health product that has been made available for sale.	N/A	Product recall record
8		Stability	52, 53(g), 56(e)	Supply records demonstrating that every natural health product complies with its specifications until its determined expiry date.	If more than 1 product type is handled by your site, supply records of stability data for 2 separate product types (e.g. herbal supplement and vitamin)	Data logs from accelerated or real-time stability studies (must show product meets its label claim at time of expiry)