QMRS Services

GOOD MANUFACTURING PRACTICES SOP's

 

Plant Housekeeping
Document Purpose: The purpose of this procedure is to define the company minimum housekeeping requirements.
Document Code: PL-001	$CAD 8.00

Storage and Handling of Received Materials
Document Purpose: The purpose of this policy is to describe the Quality Assurance requirements needed to assure appropriate storage and special handling of Health Products and other materials.
Document Code: PL-002	$CAD 10.00

Principles of Equipment Qualification
Document Purpose: The purpose of this policy is to describe the equipment qualification requirements, and to provide manufacturing personnel with guidance on the validation of manufacturing equipments, as specified under Good Manufacturing Practices of Canada Food and Drug Regulations and ICH Guideline (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients)..
Document Code: EQ-003	$CAD 60.00

Equipment Validation
Document Purpose: The purpose of this document is to provide corporate manufacturing sites with the necessary information on equipments validation requirements for sterile and non-sterile dosage forms. Utilization of this information should facilitate compliance with current GMPs.
Document Code: EQ-004	$CAD 50.00

Equipment Validation: Change Request Procedure
Document Purpose: The purpose of this procedure is to provide corporate manufacturing sites with the sequence of activities required in order to implement equipments qualification and validation.
Document Code: EQ-005	$CAD 10.00

Personal Training
Document Purpose: The purpose of this document is to establish the training system requirements to enable corporate personnel to effectively perform their assigned responsibilities and realize the impact of their actions on the Quality System.
Document Code: PE-006	$CAD 40.00

Quality Assurance Person Responsibilities
Document Purpose: The purpose of this procedure is to establish and communicate with all concerned departments the Quality Assurance Person or his/her designee Responsibilities.
Document Code: PE-007	$CAD  6.00

Approval of Disinfectants Materials
Document Purpose: This practice establishes the minimum requirements for the approval of disinfectants used within the corporate manufacturing areas, and lists all approved disinfectants for product contact or incidental product contact use.
Document Code: SN-008	$CAD   25.00

Microbial Testing of Surfaces
Document Purpose: The purpose of this procedure is to provide the corporate operating units with a description of the method for microbial testing of surfaces.
Document Code: SN-009	$CAD  15.00

Equipment Cleaning and Sanitizing Procedure
Document Purpose: The purpose of this document is to establish the system (procedure) to clean and sanitize the corporate production equipments.
Document Code: SN-010	$CAD  12.00

Equipment Cleaning: Acceptance Criteria Calculation
Document Purpose: The purpose of this procedure is to provide corporate manufacturing sites with the equation to calculate the Residual Cleaning Limit (RCL), based upon the next product to follow, for products manufactured in dedicated equipment.
Document Code: SN-011	$CAD  15.00

Equipment Cleaning: Validation Policy
Document Purpose: The purpose of this document is to describe the equipment cleaning  requirements and responsibilities.
Document Code: SN-012	$CAD  50.00

Hand Washing
Document Purpose: The purpose of this procedure is to describe the company minimum hand washing requirements.
Document Code: SN-013	$CAD  6.00

Product Manufacturing: Documentations Requirements
Document Purpose: This document is to establish the normal documentation requirements for health products manufacturing.
Document Code: OP-014	$CAD 12.00

Finished Products Tracking Number
Document Purpose: The purpose of this procedure is to describe the process for identifying each lot of finished products with a distinctive tracking number/lot number.
Document Code: OP-015	$CAD  5.00

Printed Materials Control
Document Purpose: To assure that only current and accurate approved copy is ordered by the manufacturing plants.
Document Code: OP-016	$CAD  8.00

Label Development and Control
Document Purpose: To describe the process for preparing, controlling, and approving product label, and all other printed supplies.
Document Code: OP-017	$CAD  15.00

Review and Approval of Printed Materials
Document Purpose: This SOP is to describe the process for reviewing, and approving the corporate printed/promotional material(s).
Document Code: OP-018	$CAD  10.00

Manufacturing Processes: Powder Formula
Document Purpose: This document is to outline the processing (drying, filling and packaging) of the corporate powder formulas.
Document Code: OP-019	$CAD  9.00

Non-Conforming Finished Product Control/ Product Release
Document Purpose: This policy is to control non-conforming finished product and to initiate timely corrective action to rectify the cause(s) of non-conformance.
Document Code: OP-020	$CAD  15.00

Incoming Material Specification Requirements Purpose

Document Purpose: This document outlines the incoming materials specifications and acceptance criteria.