Procedures
| Document Description | Price (USD) | Click To Purchase |
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Document Title: Management of Information Request and Deficiency Notice Document Purpose: To specify the process for managing the information requests, deficiency notices or refusal letter that received from local regulatory authorities.
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31.50 $ |
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Document Title: Management of Storage Conditions Document Purpose: To ensure that the products have been stored in a temperature-controlled environment.
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21.00 $ |
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Document Title: Manufacturing of Clinical Supply Document Purpose: To provide the procedure for the preparation (manufacturing) of clinical supplies for clinical trials in human subjects.
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31.50 $ |
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Document Title: Manufacturing Processes: Powder Formula Document Purpose: This document is to outline the processing (drying, filling and packaging) of powder formulas.
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21.00 $ |
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Document Title: Medical Devices Distribution Record Document Purpose: To define the requirements to maintain a distribution record of each device the company distributes
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52.50 $ |
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Document Title: Medical Devices Recall Follow Up Document Purpose: The purpose of this procedure is to specify the steps required for evaluating the recall’s effectiveness and the remedial actions.
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42.00 $ |
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Document Title: Medical Devices Recall Initiation & the Recall Strategy Document Purpose: This document is intended to provide instruction on identifying the need to initiate a recall and to provide guidance on how to establish/ develop the MDrecall strategy.
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105.00 $ |
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Document Title: Medical Devices Recall Reports Document Purpose: This document is intended to provide information on the recall reporting activity and.to provide instruction on the procedure of submitting the Medical Devices recall report to health Canada.
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73.50 $ |
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Document Title: Medical Devices Recall: Customers Notification & Correction Document Purpose: The objective of this document is to describe the steps to be followed to conduct an effective customers notification and correction.
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63.00 $ |
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Document Title: Medical Devices Recall: Review and Closing Document Purpose: The purpose of this procedure is to provide guidance on how to evaluate the recall’s effectiveness and how to determine if the recall is ready to be closed.
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52.50 $ |
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Document Title: Medical Devices: Documents Distribution and Control Document Purpose: The purpose of this document is to provide guidance on how the company should manage documents’ distribution and control among company employees. This is to assure that all employees are updated and well knowledgeable about the company procedures and policies changes.
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63.00 $ |
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Document Title: 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.
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31.50 $ |
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Document Title: 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.
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21.00 $ |
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Document Title: Monitoring Procedures Document Purpose: To ensure that documented monitoring procedures are established for each prerequisite program element to assess whether the programs, policies, standard operating procedures and tasks referenced in the prerequisite programs are effectively implemented and the standards are met.
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15.75 $ |
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Document Title: Natural Health Products Internal Audit Checklists (Health Canada Parameter) Document Purpose: The purpose of this procedure is to establish the tool for self-inspection and second party audit requirements to ensure that the facility is filling Health Canada regulations as indicated in the Good Manufacturing Practices Guideline Document (Natural and Non-prescription Health Products Directorate, December 1, 2015 - Version 3.0)
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210.00 $ |
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Document Title: Non-Conforming Finished Product Control Document Purpose: This procedure is to control non-conforming finished product and to initiate timely corrective action to amend the cause(s) of non-conformance.
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31.50 $ |
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Document Title: Personal Cleanliness and Health Status Document Purpose: The purpose of this document is to establish the system (procedure) to secure that employees who are handling raw or finished materials are clean.
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21.00 $ |
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Document Title: Personal Hygiene Document Purpose: To ensure that all employees in the facility are maintaining good personal hygiene practices to ensure product safety.
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21.00 $ |
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Document Title: Personnel Training Document Purpose: The purpose of this document is to establish the minimum ongoing training requirements to enable the company personnel to effectively perform their assigned responsibilities.
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70.00 $ |
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Document Title: Personnel Training Document Purpose: The purpose of this document is to establish the minimum initial and ongoing training requirements to enable the corporate personnel to effectively perform their assigned responsibilities and realize the impact of their actions on the good manufacturing practices. Document Code: D-01 Number Of Pages: 6 |
42.00 $ |
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Document Title: Pest and Insects Control Guideline Document Purpose: To provide guidelines for insects, pests’ infestation prevention and treatment of infected areas in which manufacturing and packing are carried out or raw materials or finished products are stored. Namely, to keep the plant and entire area free of insects, pests etc.
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31.50 $ |
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Document Title: Pest Control Document Purpose: This document outlines the efforts to be made to ensure that pests (Rodents and Insects) are controlled in all operational units, including the use of a licensed Pest Control Provider (PCP)
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21.00 $ |
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Document Title: Pests and Insects Control Guideline Document Purpose: To provide guidelines for insects, pests’ infestation prevention and treatment of infected areas in which packing are carried out. Namely, to keep the plant and entire area free of insects, pests etc.
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26.25 $ |
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Document Title: Plant Housekeeping Document Purpose: The purpose of this procedure is to define the company minimum housekeeping requirements (describe the general housekeeping requirements).
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21.00 $ |
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Document Title: Plant Housekeeping Document Purpose: The purpose of this procedure is to define the company minimum housekeeping requirements (To describe the general housekeeping requirements).
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15.75 $ |
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Document Title: Plant Separation of Operational Areas Document Purpose: The purpose of this procedure is to describe the process for separating manufacturing and packaging activities from non-operational areas.
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21.00 $ |
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Document Title: Plant Separation of Operational Areas Document Purpose: The purpose of this procedure is to describe the process for separating manufacturing and packaging from non-operational areas.
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15.75 $ |
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Document Title: Post- Marketing Studies Document Purpose: Is to provide guidance on conducing post-marketing surveillance studies (PMS) for Health Products.
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42.00 $ |
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Document Title: Pre-Operation Inspection Document Purpose: The purpose of this procedure is to define the procedure that the designated sanitation personnel should follow before production start-up, during operations, and after any unscheduled cleaning & sanitizing to ensure the safety of the product.
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31.50 $ |
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Document Title: Pre-Trial Documentation Document Purpose: To describe the documentation required from the principle investigator prior to release of clinical product to start the clinical phase of the trial. Document Code: CLN-004 Number Of Pages: 3 |
31.50 $ |
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Document Title: Preparation of Clinical Trial Label Document Purpose: To describe the process for preparing, and approving clinical trial labels, and other printed supplies.
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42.00 $ |
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Document Title: Prevention of Cross-Contamination Document Purpose: To reduce food borne illness by preventing unintentional contamination of food.
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15.75 $ |
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Document Title: Printed Materials (Label) Development Document Purpose: To describe the process for preparing, and developing product label, and all other printed supplies.
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21.00 $ |
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Document Title: Printed Materials Control Document Purpose: To assure that only current & accurate approved copy of labeling and printed supply is ordered by the manufacturing unit.
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21.00 $ |
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Document Title: Printed Materials: Review and Approval Document Purpose: To describe the process for reviewing and approving the corporate printed/ promotional materials.
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21.00 $ |
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Document Title: Product Complaint Document Purpose: The purpose of this policy is to describe the product complaint reporting requirements and responsibilities.
Document Code: PRD-108 Number Of Pages: 4 |
31.50 $ |
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Document Title: Product Manufacturing; Documentation Requirements Document Purpose: This document is to establish the documentation requirements (SOPs & Records), that needed by Health Products manufacturing site.
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31.50 $ |
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Document Title: Product Recall Document Purpose: The purpose of this SOP is to describe the processes for correction, withdrawal, or recall of finished marketed product for quality-related reasons, and to provide information on the recall reporting procedure.
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63.00 $ |
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Document Title: Product Recall Plan Document Purpose: This guideline is to describe the company recall plan prior to having a recall. This is to help removing unsafe product from the market quickly and efficiently.
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52.50 $ |
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Document Title: Purchasing and Qualification of Suppliers & Services Document Purpose: The purpose of this document is to define the quality assurance programs necessary for purchasing and the qualification of suppliers & services used in all company operations including packaging, storage, and distribution.
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36.75 $ |
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Document Title: QA Policy: Internal & Suppliers Audits Document Purpose: The purpose of this document is to define the requirements, responsibilities, and procedures to conduct a periodic and planned audit to ensure that corporate practices are fulfilling the current Good Manufacturing Practices regulations.
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52.50 $ |
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Document Title: QA Policy: Regulatory Inspections Practices Document Purpose: The purpose of this document is to describe the usual governmental inspection practices and recommended specific methods and standards for responding to such inspectional activities.
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105.00 $ |
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Document Title: Qualification of Suppliers and Services Providers Document Purpose: The purpose of this document is to define the quality assurance programs necessary for the qualification of suppliers and services used in the manufacturing, packaging, labelling, storage, and servicing of corporate products.
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42.00 $ |
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Document Title: 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.
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30.00 $ |
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Document Title: Quality Assurance QA Person Responsibilities Document Purpose: The purpose of this procedure is to establish and communicate with all concerned personal, the Quality Assurance Person or his/her designee Responsibilities as required by the MMPR.
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25.25 $ |
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Document Title: Quality Control Department Role Document Purpose: This guideline is to describe the function and the responsibility of the company Quality Control Department (QCD). Also, to describe the manufacturing and quality assurance personnel competency requirements.
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57.75 $ |
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Document Title: Raw Material Shipping: Suppliers Responsibilities Document Purpose: The purpose of this procedure is to establish the shipping requirements of the raw and packaging material between the suppliers and the company (manufacturer).
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31.50 $ |
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Document Title: Raw Material Testing Document Purpose: This document is to outline the process to establish the requirements for incoming Raw Material, identity testing and for other than identity testing. This is to confirm that the raw materials have the properties that will provide the desired quality, safety and efficacy or yield in each manufacturing process.
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42.00 $ |
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Document Title: Receipt and Recognition of Medical Device Problem Document Purpose: This document is to provide instructions on receipt and recognition of Medical Device Problem for conducting problem report investigations and to describes the type of information that should be gathered on a problem report.
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84.00 $ |
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Document Title: Receiving Document Purpose: This document is to ensure that all materials should be checked for proper conditions, when it is received in the facility.
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15.75 $ |
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Document Title: Records Retention and Data Storage Document Purpose: To establish the procedure to fulfill the regulatory authority’s records retention requirements and to describe the process for storage of data by corporate headquarter.
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21.00 $ |
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Document Title: Records Retention and Data Storage Document Purpose: To establish the procedure to fulfill the regulatory authority’s records retention requirements and to describe the process for storage of data by corporate headquarter. Also, to ensure that the facility has the needed records to demonstrate the effective application of the prerequisite programs and to facilitate official verifications by the competent authority.
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21.00 $ |
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Document Title: Research Ethics Board Review and Approval Document Purpose: This document is to define the function of the Research Ethics Board (REB) in clinical trials, and to define the relationship among the institution, the investigator and the REB. Document Code: CLN-009 Number Of Pages: 5 |
52.50 $ |
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Document Title: Responsibilities of Manufacturers, Importers & Distributors Document Purpose: The objective of this document is to outlines the roles and responsibilities of Medical devices manufacturers, importers and distributors. Also, to provide instructions on establishing an effective and timely system for conducting problem report investigations that complies with Health Canada requirements.
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73.50 $ |
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Document Title: Return and Destruct Supplies Document Purpose: This document is to provide the MMMD management with the necessary methodology and arrangements for returning and destruction of Marijuana products.
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52.50 $ |
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Document Title: Return and Destruction of Clinical Supplies Document Purpose: To provide the procedure for returning and destruction of clinical trials drug supplies.
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52.50 $ |
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Document Title: Return and Destruction of Product Supplies Document Purpose: This document is to provide the company with the necessary methodology and arrangements for returning and destruction of health products supplies.
Document Code: PRD-112 Number Of Pages: 3 |
31.50 $ |
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Document Title: Risk Analysis, Evaluation and Control Document Purpose: This document is to describes how the company should manage the root cause investigation, risk analysis and risk evaluation in order to comply with the Regulations.
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94.50 $ |
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Document Title: Sample Retention Document Purpose: The purpose of this document is to describe the requirements to ensure appropriate storage and managing of reserved samples.
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31.50 $ |
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Document Title: Sampling of Received Materials Document Purpose: The purpose of this procedure is to establish the requirements for the sampling of purchased chemicals, intermediates, and raw ingredients.
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42.00 $ |
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Document Title: Sanitation and Pest Control Document Purpose: This document outlines the efforts to be made to ensure that pests (Rodents and Insects) are controlled in all operational units, including the use of a licensed Pest Control Operator (PCO).
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26.25 $ |
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Document Title: Sanitation Policy Document Purpose: The purpose of this policy is to provide the company Quality Assurance Manager and employees with a description of the method for cleaning and sanitation programs requirements.
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105.00 $ |
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Document Title: Sanitation Policy Document Purpose: The purpose of this policy is to provide the company Quality Assurance Manager and employees with a description of the method for cleaning and sanitation programs requirements. Document Code: E-01 Number Of Pages: 6 |
42.00 $ |
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Document Title: Shipment of Clinical Supply Document Purpose: This SOP is to describe the shipping requirements of clinical trials supplies.
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73.50 $ |
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Document Title: Site Master File Document Purpose: To define the documents required to be established and maintained by the clinical investigator before, during, and after the completion or discontinuation of a clinical trial.
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73.50 $ |
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Document Title: Site Security Measures Senior Management Tasks Document Purpose: The objective of this document is to establish the senior management (The Senior Responsible Person in Charge and the Responsible Person in Charge’ (RPIC) tasks and procedures to comply with “Division (3) security measure requirements” of the Marijuana for Medical Purposes Regulations (MMPR) |
94.50 $ |
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Document Title: Sponsor Responsibilities Document Purpose: To define the Institute responsibilities as a sponsor for conducting clinical trials according to ICH: GCP Guideline. Document Code: CLN-006 Number Of Pages: 13 |
105.00 $ |
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Document Title: Stability Testing Document Purpose: The purpose of this policy is to define the stability data requirements to ascertain the normal shelf life of the products. That is to determine how long the products can be expected to remain within specifications under recommended storage conditions and label claim. Document Code: PRD-104 Number Of Pages: 16 |
126.00 $ |
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Document Title: Storage and Handling of Received Materials Document Purpose: The purpose of this document is to describe the Quality Assurance requirements to assure appropriate storage and special handling of health products and other materials.
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21.00 $ |
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Document Title: Storage and Handling of Received Materials Document Purpose: The purpose of this policy is to describe the Quality Assurance requirements to assure that all food, chemicals, and supplies are stored in a manner that ensures quality and maximizes safety of food.
This is to ensure that the food products have been stored in a temperature-controlled environment according to the CFIA and label requirements.
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31.50 $ |
