Drug GMP SOPs & Policies
These documents are written according to the guidelines on drug Good Documentation Practices (GDPs) established by Health Canada, the US-FDA, and WHO. Accordingly, these SOPs should fulfill the Non-Prescription drug GDPs as well as the Dietary Supplements and Natural Health Products. Please note that these SOPs need to be modified according to the facility size, types of activities and the site personnel competencies.
Procedures
| Document Description | Price (USD) | Click To Purchase |
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Document Title: A List of Required GMP Procedures Document Purpose: To provide a proposed list of SOPs that the manufacturing facility needs to develop to fulfill the basic GMP requirements This is to ensure that there are Procedures in place for every operation/activity the company carries out.
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52.50 $ |
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Document Title: Approval of Disinfectant Materials Document Purpose: This document establishes the minimum requirements for the approval of disinfectants used within the corporate manufacturing |
21.00 $ |
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Document Title: Change Control Procedure Document Purpose: The purpose of this procedure is to provide corporate manufacturing sites with the sequence of activities used to document initiation of change control program activities.
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52.50 $ |
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Document Title: Cleaning and Sanitizing of Product Contact Surfaces Document Purpose: To ensure that product contact surfaces are properly cleaned and sanitized.
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21.00 $ |
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Document Title: Communication with Regulatory Authorities Document Purpose: To define the requirements for reporting and retaining information compiled from communications with local regulatory authorities.
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21.00 $ |
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Document Title: Corrective and Preventive Action Policy (CAPA) Document Purpose: The purpose of this document is to describe the approach to review quality system data to identify, correct, and prevent non-conformities.
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52.50 $ |
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Document Title: Determination of Product Shelf-Life Document Purpose: The purpose of this procedure is to define the methods used 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.
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31.50 $ |
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Document Title: Dietary Supplements Internal Audit Checklists (US FDA 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 fulfilling US FDA regulations as indicated in USA Department of Health and Human Services Food and Drug Administration 21 CFR Part 111, final rule guidance document on “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements”.
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420.00 $ |
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Document Title: Documentation and Storing of Received Materials Document Purpose: The purpose of this procedure is to establish the process of documenting and storing raw materials until they are released by the QA for testing.
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21.00 $ |
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Document Title: Documents Creation (SOP on SOPS) Document Purpose: To describe the process for creating, updating, or revising the corporate, standard operating procedures (SOPs), policies and guidelines. All referred to collectively, herein, as "documents”.
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31.50 $ |
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Document Title: Documents Distribution and Control Document Purpose: The purpose of this document is to establish the system to control and manage documents distribution among corporate employees. This is to assure that all employees are updated and well-knowledgeable about the corporate procedures and policies changes.
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52.50 $ |
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Document Title: Drug 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, based on Health Canada; Drugs & Health Products Regulations (GMPs Guidelines, 2018 Edition, (GUI-0001).
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315.00 $ |
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Document Title: Drug Refrigeration and Temperature Monitoring Document Purpose: The purpose of this document is to provide guidance to medicinal products wholesaler’s staff in relation to conditions for cold storage. This is to ensure continuity of the ‘cold-chain’ while these products are under the wholesaler’s care.
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63.00 $ |
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Document Title: 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 equipment.
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31.50 $ |
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Document Title: Equipment Cleaning Validation Policy Document Purpose: The purpose of this document is to describe the corporate cleaning validation requirements for equipments used in the manufacture of pharmaceutical products, and biological drugs.
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147.00 $ |
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Document Title: Equipment Cleaning: Acceptance Criteria Calculation Document Purpose: The purpose of this procedure is to provide corporate QA Person with the equation to calculate the Residual Cleaning Limit (RCL), based upon the next product to follow, for products manufactured in dedicated equipment.
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31.50 $ |
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Document Title: Equipment Design Requirements Document Purpose: This SOP is to define the company equipment's design policy to ensure product safety.
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21.00 $ |
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Document Title: Equipment Qualification Document Purpose: The purpose of this policy is to describe the equipment qualification requirements, as specified in the International Conference on Harmonization (ICH) Guideline; “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
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157.50 $ |
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Document Title: Equipment Validation Guideline 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.
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115.50 $ |
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Document Title: Exterior Monitoring Procedure Document Purpose: The purpose of this procedure is to describe the method how the facility exterior monitoring process should be conducted.
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21.00 $ |
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Document Title: Facility Maintenance Document Purpose: The purpose of this procedure is to define the company minimum facility maintenance requirements to ensure the safety of the finished products.
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52.50 $ |
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Document Title: Finished Products Specifications Document Purpose: The objectives of this document are: (1) To establish standards for the identity, purity, quantity/potency and tolerances of finished product. (2) To describe tests, test methods and acceptance criteria, ranges or other criteria for the tests described. And (3) To establish the parameters to which finished products must conform to be acceptable for their intended use.
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52.50 $ |
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Document Title: Finished Products Testing and Release Document Purpose: The purpose of this document is to describe the procedure (Steps), which are required before releasing finished product for sale. This is to ensure the quality (identity, purity and quantity) of finished products.
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63.00 $ |
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Document Title: 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.
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21.00 $ |
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Document Title: Functions of Quality Assurance Department Document Purpose: This guideline is to describe the function and specify the responsibility of the company Quality Assurance Department (QAD). Also, to indicate the manufacturing & QA personnel competency needs and the minimum requirements to establish an adequate sanitation program including the employee’s hygiene.
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73.50 $ |
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Document Title: Good Documentation Practices Guideline Document Purpose: This guideline provides the framework for documentation management. The framework includes document development process, document values, property, categories, types, and document templates.
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105.00 $ |
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Document Title: Hand Washing Document Purpose: The purpose of this procedure is to describe the company minimum hand washing requirements to prevent illness by contaminated hands.
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21.00 $ |
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Document Title: Handling Out of Specifications Microbial Results Document Purpose: Is to lay down a procedure for handling out-of-specifications microbiological testing results.
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21.00 $ |
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Document Title: Incoming Material Specifications Document Purpose: This SOP is to outline the corporate incoming materials specifications and acceptance criteria requirements.
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63.00 $ |
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Document Title: Line Clearance Document Purpose: This SOP describes the procedure and direction to be followed when performing a Line clearance, Line opening and Line cleaning for a batch production.
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21.00 $ |
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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 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: 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: 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 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: 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: 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 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: 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: 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: 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: 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: 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: 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: 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 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: 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: Suppliers Certificate of Analysis Document Purpose: To describe the process for obtaining a complete Certificate of Analysis (COA) from suppliers, and to establish the responsibilities for transmitting and maintaining the record for raw incoming material and finished products.
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21.00 $ |
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Document Title: Thermometer Using and Calibrating Document Purpose: To ensure that thermometers used are correctly and frequently calibrated for accuracy.
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21.00 $ |
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Document Title: Third Party Laboratory Testing Document Purpose: The purpose of this procedure is to establish the requirements and responsibilities for the use of third-party laboratory testing services.
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21.00 $ |
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Document Title: Warehouse Mapping and Temperature Monitoring Document Purpose: This document is to ensure that all health products in the warehouse are being stored at its specified conditions with the objective to fulfil the GMP regulatory requirements.
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31.50 $ |
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Document Title: Waste Management Document Purpose: The purpose of this procedure is to define the company minimum facility waste management requirements to ensure compliance with the corporate policy
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21.00 $ |
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Document Title: Water System And quality Document Purpose: This document is to provide guidance on the facility essential requirements for water system quality and design.
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52.50 $ |
