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: 

1. Good Manufacturing Practices (GMPs) and Quality Assurance SOPs

2. Good Clinical Practices (GCPs) SOPs

Please visit the above links for more details on our work scope and approach.

 

Good Manufacturing Practices (GMPs) and Quality Assurance

 

 

 

         SOPs for Good Manufacturing Practices (GMPs) and Quality Assurance

SOP No.	SOP TITLE	Details for Buyer
PL-001	Plant Housekeeping	more info
PL-002	Storage and Handling of Received Materials	more info
EQ-003	Principles of Equipment Qualification	more info
EQ-004	Equipment Validation	more info
EQ-005	Equipment Validation: Change Request Procedure	more info
PE-006	Personnel Training	more info
PE-007	Quality Assurance Person Responsibilities	more info
SN-008	Approval of Disinfectants Materials	more info
SN-009	Microbial Testing of Surfaces	more info
SN-010	Equipment Cleaning and Sanitizing Procedure	more info
SN-011	Equipment Cleaning: Acceptance criteria calculation	more info
SN-012	Equipment Cleaning Validation Policy	more info
SN-013	Hand Washing	more info
OP-014	Product Manufacturing: Documentations Requirements	more info
OP-015	Finished Products Tacking Number	more info
OP-016	Printed Materials Control	more info
OP-017	Label Development and Control	more info
OP-018	Review and Approval of Printed Materials	more info
OP-019	Manufacturing Processes: Powder Formula	more info
OP-020	Non-conforming Finished Product Control/ Product Release	more info
OP-021	Incoming Material Specification Requirements	more info
OP-022	Sampling of Received Materials	more info
OP-023	Certificate of Analysis	more info
OP-024	Third Party Laboratory Testing	more info
OP-025	Product Recall	more info
OP-026	Product Complaint	more info
OP-027	Corrective and Preventive Action (CAPA)	more info
OP-028	Stability Testing	more info
OP-029	Sample Retention	more info
OP-030	Documents (SOPs & Policies Distribution and Control	more info
OP-031	Documents Creation (SOP on SOPs)	more info
OP-032	Records Retention and Data Storage	more info
OP-033	Communication with Regulatory Authorities	more info
OP-034	Managing Information Request and Deficiency Notice	more info

 

 

 

SOPs for Clinical Trials Standard Operating  Procedur

SOP No.	SOP TITLE	Details for Buyer
SSP-001	Clinical Trials: Regulatory requirements	more info
SSP-002	Clinical Trials: Principles	more info
SSP-003	Post-Marketing Studies	more info
SSP-004	Contract Research Organization	more info
SSP-005	Pre-trial Documentation	more info
SSP-006	Investigator Selection	more info
SSP-007	Clinical Trials: Sponsor Responsibilities	more info
SSP-008	Clinical Trials: Investigator Responsibilities	more info
SSP-009	Clinical Trials: Confidentiality Agreement	more info
SSP-010	Research Ethics Board Review/Approval	more info
SSP-011	Informed Consent Form	more info
SSP-012	Clinical Case Report	more info
SSP-013	Site Master File	more info
SSP-014	Trial Master File	more info
SSP-015	Clinical Supply Accountability	more info
SSP-016	Investigational product Adverse Event Reporting	more info
SSP-017	Manufacturing of Clinical Supply	more info
SSP-018	Preparation of Clinical Trial Label	more info
SSP-019	Shipment of Clinical Supply	more info
SSP-020	Investigational Product Recall	more info
SSP-021	Return and Destruction of Clinical Supply	more info
SSP-022	Management of Expired and Extended Investigational Supply	more info
SSP-023	Clinical Trial Training Requirements	more info
SSP-024	Declaration of Helsinki	more info
SSP-025	Clinical Trial Audit	more info