Natural Health Products Directorate - Direction des produits de santé naturels

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1 Site Licensing & Good Manufacturing Practices Requirements for Natural Health Products in Canada Canadian Association of Professional Regulatory Affairs Annual Education Day - June 5, 2012 Raymond W. Tsang, M.Sc. Manager, Site Licence Assessment & Coordination Division Natural Health Products Directorate Health Products & Food Branch, Health Canada 1

2 Presentation Outline: Natural Health Products Directorate of Health Canada Site Licensing (SL) Good Manufacturing Practices (GMP) Differences and Similarities between Drug and Natural Health Product GMP References 2

3 Natural Health Products Directorate: was created in 2000 as part of the Health Products and Food Branch (HPFB) of Health Canada 3

4 Natural Health Products Directorate: Mission: To ensure that all Canadian have ready access to natural health products that are safe, effective and of high quality while respecting freedom of choice and philosophical and cultural diversity 4

5 Natural Health Products Regulations (Jan 2004): Part 1 Product Licences Part 2 Site Licences Part 3 Good Manufacturing Practices Part 4 Clinical Trials Involving Human Subjects Part 5 Packaging & Labelling Part 6 Transitional Provisions Site (Dec 31, 2005); Product (Dec 31, 2009) 5

6 Part 1 - Product Licences: Amino Acids Enzymes Essential Fatty Acids Herbal Medicines Homeopathic Medicines Isolates Minerals Probiotics Traditional Herbal Medicines Vitamins Safety --- Efficacy --- Quality Product Specifications Good Manufacturing Practices (GMP) 6

7 Site Licence Performance (Jan 1, Mar 31, 2012) 2003 / / / / / / / / /12 TOTAL: Overall Completion New % Amendment % Notification % Renewal % TOTAL:

8 Site & Assessment Breakdown (Canada & Foreign Manufacturing Sites) British Columbia % Alberta % Saskatchewan 6 0.7% Manitoba % Ontario % Quebec % Prince Edward Island 2 0.3% New Brunswick 2 0.3% Nova Scotia % Newfoundland 3 0.4% Northwest Territories 1 0.1% TOTAL (Active Sites) % 1 United States % 2 China % 3 France % 4 Germany % 5 United Kingdom % 6 Denmark % 7 Switzerland % 8 Australia % 9 Japan % 10 India % 11 Others % TOTAL: (Sites Assessed) % 8

9 Noted GMP & Product Concerns Adulteration (e.g. undeclared substances, prescription drugs, allergenic ingredients) Labelling errors (e.g. wrong label, wrong risk information) Good Manufacturing Practices (e.g. product mix-ups, not following to standard operating procedures, stability) Microbial Contamination (e.g. E. Coli, Salmonella, Mould) Heavy Metal Contamination (e.g. lead, mercury, arsenic) 9

10 Site Licensing (SL) SL Requirements Commonly Noted Challenges 10

11 What is a Site Licence? A legal authorization document issued by Health Canada that includes: The name and address of the licensee; The site licence number; Each activity that the licensee is authorized to conduct in respect of a natural health product (NHP) in sterile, homeopathic and/or non sterile dosage forms; The address of each building that is authorized to manufacture, package, label, import and/or store NHPs in Canada and/or foreign sites; and The expiry date of the licence. 11

12 Who requires a Site Licence? Manufacturers of NHPs Packagers of NHPs Labellers of NHPs Importers of NHPs 12

13 Who does not require a Site Licence? Storage/warehouse sites of NHPs* Foreign manufacturers, packagers and labellers* Distributors of NHPs ** * These sites are annexed on the Site Licence ** Any imported NHP drop off site in Canada is considered to be a storage/warehouse site and must be annexed on the Importer s Site Licence 13

14 Who does not require a Site Licence? Compounding activity by a health care practitioner, or a pharmacist in the context of a practitioner-patient relationship "Secondary packaging (not putting product in its immediate container) 14

15 Note: Site Licence for Importing Must have at least one foreign site Canadian Site + Foreign Site = Site Licence for Importing 15

16 SL Application Types: New Amendment (adding new activity, building and/or sterile dosage) Notification (administrative information) Renewal No cost at this time 16

17 Contents of the SL Application: Applicant s Information (name, address, Tel #, Fax #, address) Activities: Manufacturing (M), Packaging (P), Labelling (L) and/or Importing (I) Each building for M, P, L, I and/or Storing (S) Sterile dosage Report from a Quality Assurance Person per building/site 17

18 Report from a QAP or Quality Assurance Report (QAR): Demonstrate good manufacturing practices (GMP) compliance 22 GMP questions: Description of compliance, or rationale if not completed Listing of standard operating procedures (SOPs) GMP observations, corrective action plan and timeline SOPs and/or records within past 12 months 18

19 Sample of a QAR: 19

20 Acceptable GMP evidence: Quality Assurance Report (QAR) Drug Establishment Licence (DEL) Certificate of Compliance of Regulatory Authority (Mutual Recognition Agreement Countries) USFDA Establishment Inspection Report (EIR) / 483 Letter and corrective actions Other valid GMP Inspection Reports (additional info may be requested) 20

21 Site Licence Renewal Cycle: Confidence Building Approach: Annual (1 to 3 years) Once every two years (4 to 9 years) Once every three years (9 years and over) Use QAR or Summary of Net Changes (SNC) depending on the renewal cycle (See in the Site Licence GD) 21

22 Site Licensing Process: Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Site Licence Application Application Screening Submission Screening Good Manufacturing Practices Assessment Recommendation: SL Issuance, or SL Refusal Site Licence Approval & Issuance Site Licence Applicant NHPD Submission Management Division NHPD Site Licence Assessment & Coordination Division NHPD Director s General Office 22

23 Noted challenges - SL Applications: Applications submitted by and fax Missing key information in the SL application form Relocation of the site(s) before authorization No foreign site listed in the SL application for importers Importing NHPs before authorization Do not respond to Information Request Notices (IRNs) within the set timeline (e.g. 30 days), or no response 23

24 Noted challenges - SL Renewal Applications: Forgot to renew the site licence on time GMP corrective actions from previous year were not completed Combining amendment of new site at renewal 24

25 Noted challenges - GMP Information: No evidence of GMP compliance provided for the site(s) Questions in the QAR were neither completed nor any rationale provided No SOP/GMP records provided with QAR/SNC GMP records are not from within the past 12 months Evidence of GMP compliance for foreign site is not provided in one of the official languages 25

26 Noted challenges (Consultant or Third Party QAP): Late submission of the SL renewal application Unfamiliar with SL and GMP requirements Use of the same generic SOPs for all clients No involvement with the firm after the site licence issuance 26

27 Good Manufacturing Practices (GMP) GMP Requirements Commonly Noted Challenges 27

28 What are GMPs? Ongoing measures to ensure effective overall approach to quality and risk management. A system of processes, procedures and documentation to set the appropriate standards and practices for manufacturing, packaging, labeling, importing and storage activities. Regulations under Part 3 of the NHPR. Interpretations are provided in the NHP GMP Guidance Document 28

29 Who must comply with GMPs? Manufacturers Packagers Labellers Importers Distributors Storage facilities 29

30 What are the 12 key GMP sections in the Natural Health Products Regulations? Specifications Premises Equipment Personnel Sanitation Program Operations s44 Quality Assurance s45 Stability s46 Records s47 Sterile Product s48 Samples s49-50 Recall Reporting s51 s52 s53-58 s59-60 s61 s62 30

31 NHP GMP sections can be grouped into 4 headings (the 4Ps) 2 1 PLACES PROCESSES 3 PEOPLE PRODUCTS 4 1 PLACES: Premises, Equipment 2 PEOPLE: Personnel, Quality Assurance 3 PROCESSES: Sanitation, Operations 4 PRODUCTS: Specifications, Stability, Records, Sterile, Samples, Recall Reporting 31

32 1 PLACES: Premises, Equipment 2 PEOPLE 1 PLACES PROCESSES PRODUCTS

33 GMP Premises (s45) Expectations Facility must be of appropriate size and designed and maintained for its intended use: Environmental control Pest control Ventilation Plumbing Water supply 33

34 GMP Equipment (s46) Expectations All equipment must be designed, constructed, installed, maintained and operated in a way to: Facilitate cleaning Facilitate sanitizing Prevent contamination of the NHP Permit it to function in accordance with its intended use 34

35 2 PEOPLE: Personnel, Quality Assurance 2 PEOPLE 1 PLACES PROCESSES PRODUCTS

36 Personnel (s47) Expectations GMP All personnel must have appropriate training, education or experience to perform their respective tasks. Written job descriptions Maintain records of education and training Update when needed 36

37 GMP Quality Assurance (s51) Expectations Every manufacturer, packager, labeller, importer and distributor must have a qualified quality assurance person (QAP) who is responsible for: GMP compliance and operations of the site Approval or rejection Release of finished product Complaint handling 37

38 3 PROCESSES: Sanitation, Operations 2 PEOPLE 1 PLACES PROCESSES PRODUCTS

39 GMP Sanitation Program (s48) Expectations Must have: Equipment and/or facility sanitation programs, and Health and hygiene program 39

40 GMP Operations (s49 & 50) Expectations Must develop written standard operating procedures to ensure the activity is performed correctly and consistently Procedures for every aspect of operations Recall procedures Update procedures as necessary 40

41 4 PRODUCTS: Specifications, Stability, Records, Sterile, Samples, Recall Reporting 2 PEOPLE 1 PLACES PROCESSES PRODUCTS

42 GMP Specifications (s44) Expectations Must ensure every batch or lot meets the established specifications. Detailed information with respect to: Identity Quantity Purity (e.g. microbiological and chemical contaminants) Potency (if applicable) Any changes must be approved by the QAP 42

43 GMP Stability (s52) Expectations Must ensure that product will continue to meet its approved specifications at the time of product expiry after being packaged for sale. Establish the shelf life based on accelerated and/or real time stability studies Initial determination may be based on similar product formulations 43

44 GMP Records (s53-58) Expectations Must ensure that records are maintained for a period of one year past the expiry date of the lot or batch of the product. Manufacturers Packagers Labellers Importers Distributors 44

45 GMP Sterile NHPs (s59-60) Expectations Must treat all sterile NHPs in the same manner as any other sterile health product (e.g. drugs). Health Canada s Health Products and Food Branch Inspectorate s Good Manufacturing Practices Guidelines (GUI-0001) 45

46 GMP Samples (s61) Expectations Must retain an adequate number of samples from each lot of finished product. Sufficient quantity and in identical packaging One year past the expiry of the product Alternate sample retention 46

47 GMP Recall Reporting (s62) Expectations Must inform Health Canada within 3 days of commencing a recall. Information to provide is listed under section 62 of the NHPR Report to your Regional Operational Centre 47

48 Regional Inspectorate Program Atlantic Region 1505 Barrington Street, 16 th floor, suite 1625 Halifax, Nova Scotia B3J 3Y6 Telephone: ; Toll Free: Provinces: Nova Scotia, New Brunswick, Prince Edward Island and Newfoundland Quebec Region 1001 St-Laurent Street West Longueuil, Quebec J4K 1C7 Telephone: ; Toll Free: Province: Quebec Ontario Region 2301 Midland Avenue Toronto, Ontario M1P 4R7 Telephone: ; Toll Free: Province/Territory: Ontario and Nunavut Manitoba and Saskatchewan Region 510 Lagimodière Blvd Winnipeg, Manitoba R2J 3Y1 Telephone: ; Toll Free: Provinces: Manitoba and Saskatchewan Alberta Region Jasper Ave. Edmonton, Alberta T5J 4C3 Telephone: ; Toll Free: Province/Territory: Alberta and Northwest Territories British Columbia Region Suite Canada Way Burnaby, British Columbia V5G 1J9 Telephone: Toll Free: Province/Territory: British Columbia and Yukon

49 Commonly noted GMP challenges 1. Product specifications 2. Stability 3. Finished product testing and QA release procedures 4. Roles and responsibilities of the QAP 5. Corrective action plans 6. Documentation practices 7. SOPs 8. Batch records 9. Master production document 10. Contract manufacturers/pl holders (roles and responsibilities) 49

50 Differences & Similarities between the Natural Health Product & Drug GMP: GMP NHPR (No Validation) FDA (Validation) Places Premises 45 C Equipment 46 C People Personnel 47 C Quality Assurance (QA Person) 51 (Quality Control Department) C C C Processes Sanitation 48 C.O2.007 (Sanitation Program) C (Hygienic Behaviour) Operations 49 Manufacturing Control C (Written Procedures) C (System of Control) 50

51 Differences & Similarities between the Natural Health Product & Drug GMP: GMP NHPR FDA Products Specifications 44 Identity Purity Quantity Potency Test Methods Raw Material Testing C C Packaging Material Testing C C Finished Product Testing C C

52 Differences & Similarities between the Natural Health Product & Drug GMP: GMP NHPR FDA Products Records 53 (Manufacturers) 54 (Packagers) 55 (Labellers) 56 (Importers) 57 (Distributors) 58 (Maintenance) C (F, P/L, D & I)* C (Maintenance) C (D, W & I) C (Complaint) C (Self inspection & Sanitation program) Stability 52 C (Establish stability period) C (Continuing Program) Sterile 59 & 60 C Samples 61 C (Retain sample by lot) C (Keep sufficient amount) Recall Reporting 62 * F = Fabricator; P/L = Packager/Labeller; D = Distributor; I = Importer, W = Wholesales 52

53 References: 53

54 Guidance Documents: Site Licence GD => Good Manufacturing Practices GD => Evidence for Quality of Finished NHPs GD => 54

55 Tracking Database: Licensed Natural Health Products Database => Natural Health Products Exempted Products Database => Natural Health Products Ingredients Database => Controlled Vocabulary Search (Test Methods) => 55

56 NHP Enquiries ( addresses): Site Licence / Good Manufacturing Practices / International Trade Certificate => Product Licence => Clinical Trials => General NHPD => 56

57 Questions Site Licensing Licence d exploitation Good Manufacturing Practices Bonnes pratiques de fabrication 57

58 THANK YOU Natural Health Products Directorate Health Products & Food Branch, Health Canada 58

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