QMRS Services
DOCUMENTATION SUPPORT
The value of good documentation is well described in quality assurance publications. In brief, it enables communications of intent and consistency of actions (ISO 9000: 2000). It is obvious that a company adequate documentation of the quality assurance policies and procedures is an essential element of the quality management system fundamentals. As per Appendix II of the Natural Health Products Directorate: GMP guidance document, Health Canada requires manufacturers to retain in the premises 16 types of records. The absence of any of these records will be considered ‘Risk One’ observation, which may result in a non-compliant rating. The organization that aim to establish Good Documentation Practices, needs to develop a number of documents, which, should include (but not limited to):
ü Quality assurance documents (policies, guidelines, and SOPs)
ü Product specifications (sampling, regulatory specifications)
ü Materials specifications (raw materials, process materials)
ü Manufacturing documents (formulation/process specifications)
ü Testing documents (test methods)
ü Packaging documents (packaging materials summary)
ü Training module
ü Stability reports
QMRS understands the challenge facing health products manufacturers and importers in Canada and overseas. Our intention is to be distinguished from others by providing health products industry with a specialized expertise, focusing solely on this specific line of the pharmaceutical industry. Therefore, we have developed many documents written in accordance with Health Canada: Health Products Regulations. These documents are:
Please visit the above links for more details on our work scope and approach.
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Quality Assurance SOPs |
The following table contains a list of policies, which QMRS is ready to provide you with. Upon your request, QMRS would be pleased to send you the table of contents of any of these policies to review. Just send us your request by email to info@qmrs.com, and promptly, we will send you a summary of the policy you requested.
AVAILABLE SOPs FOR COMPLETING THE QUALITY ASSURANCE REPORT FORM
SOP NO.
SOP TITLE
GMPs ELEMENTS
NO. OF PAGES
OP-022
Incoming Material Specification Requirements Critical Processes
3
OP-023
Sampling of Received Materials Critical Processes
4
OP-024
Certificate of Analysis Critical Processes
2
OP-025
Self Inspection and GMPs Checklist Self Inspection
28
OP-026
Third Party Laboratory Testing Inspection Program
2
OP-027
Product Recall Operation
4
OP-028
Product Complaint Operation
2
OP-029
Corrective and Preventive Action (CAPA) Operation
4
OP-030
Stability Testing Stability
14
OP-031
Sample Retention Samples
2
OP-032
Manufacturing: Documentations Requirements Records
4
OP-033
Documents Creation (SOP on SOPs) Records
5
OP-034
Documents (Procedures & Policies): Distribution and Control Records
4
OP-035
Record Retention and Data Storage Records
2
OP-036
Communication with Regulatory Authorities Records
3
OP-037
Managing Information Request and Deficiency Notice Records
4
OP-038
Product Recall Recall Reporting
4
Good Manufacturing Practices (GMPs) SOPs
AVAILABLE GOOD MANUFACTURING PRACTICES (GMPs) SOPs
SOP No. SOP TITLE
GMPs ELEMENTS PL-001 Plant Housekeeping Premises PL-002 Storage and Handling of Received Materials Premises EQ-003 Principles of Equipment Qualification Equipment EQ-004 Equipment Validation Equipment EQ-005 Equipment Validation: Change Request Procedure Equipment PE-006 Personnel Training Personnel PE-007 Quality Assurance Person Responsibilities Quality Assurance SN-008 Approval of Disinfectants Materials Sanitation Program SN-009 Microbial Testing of Surfaces Sanitation Program SN-010 Equipment Cleaning and Sanitizing Procedure Sanitation Program SN-011 Equipment Cleaning: Acceptance criteria calculation Sanitation Program SN-012 Equipment Cleaning Validation Policy Sanitation Program SN-013 Hand Washing Sanitation Program OP-014 Product Manufacturing: Documentations Requirements Material control OP-015 Finished Products Tacking Number Material control OP-016 Printed Materials Control Material control OP-017 Label Development and Control Critical Processes OP-018 Review and Approval of Printed Materials Critical Processes OP-019 Manufacturing Processes: Powder Formula Critical Processes OP-020 Non-conforming Finished Product Control/ Product Release Critical Processes OP-021 Incoming Material Specification Requirements Critical Processes OP-022 Sampling of Received Materials Critical Processes OP-023 Certificate of Analysis Critical Processes OP-024 Third Party Laboratory Testing Inspection Program OP-025 Product Recall Operation OP-026 Product Complaint Operation OP-027 Corrective and Preventive Action (CAPA) Operation OP-028 Stability Testing Stability OP-029 Sample Retention Samples OP-030 Documents (SOPs & Policies Distribution and Control Records OP-031 Documents Creation (SOP on SOPs) Records OP-032 Records Retention and Data Storage Records OP-033 Communication with Regulatory Authorities Records OP-034 Managing Information Request and Deficiency Notice Records
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Good Clinical Practice (GCP) |
A list of Available Clinical Trials Standard Operating Procedures
SOP CODE
SOP TITLE
No. OF PAGES
SSP-001
Clinical Trials: Regulatory requirements
2
SSP-002
Clinical Trials: Principles
5
SSP-003
Post-Marketing Studies
5
SSP-004
Contract Research Organization
6
SSP-005
Pre-trial Documentation
3
SSP-006
Investigator Selection 2
SSP-007
Clinical Trials: Sponsor Responsibilities 17
SSP-008
Clinical Trials: Investigator Responsibilities
13
SSP-009
Clinical Trials: Confidentiality Agreement
4
SSP-010
Research Ethics Board Review/Approval
7
SSP-011
Informed Consent Form
14
SSP-012
Clinical Case Report
7
SSP-013
Site Master File
7
SSP-014
Trial Master File
8
SSP-015
Clinical Supply Accountability
12
SSP-016
Investigational product Adverse Event Reporting
6
SSP-017
Manufacturing of Clinical Supply
4
SSP-018
Preparation of Clinical Trial Label
5
SSP-019
Shipment of Clinical Supply
8
SSP-020
Investigational Product Recall
6
SSP-021
Return and Destruction of Clinical Supply
5
SSP-022
Management of Expired and Extended Investigational Supply
2
SSP-023
Clinical Trial Training Requirements
13
SSP-024
Declaration of Helsinki
7
SSP-025
Clinical Trial Audit
11
