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: Allergen Control Program Document Purpose: The purpose of this document is to control the use of ingredients identified as allergens in the facility, as well as to prevent cross contamination with undeclared allergen ingredients in finished food products. Generally, the purpose of the allergen control program is to gather all the allergen controls in one location in the HACCP system.
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21.00 $ |
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Document Title: Allergens, Nutrients, Additives & Processing Aids Policy Document Purpose: The purpose of this document is to control the use of ingredients identified as allergens, as well as the use of Food Processing Aids and food additives.
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36.75 $ |
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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: Approval of Disinfectant Materials Document Purpose: This document establishes the minimum requirements for the approval of disinfectants used within the corporate manufacturing areas.
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21.00 $ |
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Document Title: Building Surroundings, Design, Construction and Layout Document Purpose: This document provides guidance on the essential requirements for the facility buildings design, construction and layout to meet the MMPR requirements
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42.00 $ |
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Document Title: Building Surroundings, Design, Construction and Layout Document Purpose: This document provides guidance on the essential requirements for facility buildings design, construction and layout to meet the CFIA HACCP programs requirements.
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31.50 $ |
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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 Sanitation Policy Document Purpose: The purpose of this policy is to provide the company QA person and employees with a description of the method for Cleaning & Sanitation Programs policy and procedures.
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52.50 $ |
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Document Title: Cleaning and Sanitizing of Food Contact Surfaces Document Purpose: To prevent food borne illness, by ensuring that all food contact surfaces are properly cleaned and sanitized.
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15.75 $ |
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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: Clinical Case Report Form Document Purpose: To provide instructions to Institute “Clinical Research Associates’ and other clinical project team members, on managing and handling clinical case reports.
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63.00 $ |
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Document Title: Clinical Supply Accountability Document Purpose: To describe the accountability requirements for clinical trials supplies.
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84.00 $ |
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Document Title: Clinical Trial Audit Document Purpose: To define the procedure for clinical investigator site auditing to determine that the organization quality management system is fulfilling ICH standard and local regulations.
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94.50 $ |
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Document Title: Clinical Trial Master File Document Purpose: To define the documents that must be retained in the Clinical Trial Master File.
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73.50 $ |
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Document Title: Clinical Trials Confidentiality Agreement Document Purpose: This SOP is to provide a protection of information proprietary to Institute (the corporate). Document Code: CLN-008 Number Of Pages: 4 |
42.00 $ |
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Document Title: Clinical Trials Investigator Responsibilities Document Purpose: To define the responsibilities of the investigator who is involved in clinical research concerning human subjects. Document Code: CLN-007 Number Of Pages: 11 |
105.00 $ |
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Document Title: Clinical Trials Principles Document Purpose: To provide general principles for conducting clinical trials in human subjects Document Code: CLN-001 Number Of Pages: 3 |
31.50 $ |
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Document Title: Clinical Trials Regulatory Requirements Document Purpose: To specify the Regulatory Authorities requirements for conducting clinical trials involving human subjects. Document Code: CLN-002 Number Of Pages: 2 |
31.50 $ |
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Document Title: Clinical Trials Training Requirements Document Purpose: To describe the requirements for clinical trials training, and the procedures to conduct and document clinical training.
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105.00 $ |
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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: Contents of The Mandatory Problem Report Document Purpose: The purpose of this procedure is to provide guidance on the preliminary and final report contents, concerning mandatory problem reporting. |
63.00 $ |
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Document Title: Contract Research Organization Document Purpose: This is to specify the procedure for transferring the Institute responsibilities, pertaining to clinical trials activities from Institute to a second party (a Contract Research Organization) Document Code: CLN-003 Number Of Pages: 5 |
52.50 $ |
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Document Title: Contract Research Organization (CRO) Evaluation; Organization Capabilities Checklist Document Purpose: Is to provide the tool for evaluating the Clinical Research Organization Capabilities, based on ICH |
42.00 $ |
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Document Title: Contract Research Organization Evaluation (CRO): Clinical Laboratory Evaluation Checklist Document Purpose: The purpose of this checklist is to provide the tool for evaluating the Clinical Laboratory Capabilities, based on ICH guidelines. |
42.00 $ |
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Document Title: Contract Research Organization Evaluation (CRO): Investigational Site Capabilities Checklist Document Purpose: Is to provide the tool for evaluating the Investigational Site Capabilities, based on ICH guidelines. |
63.00 $ |
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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: Deviation Procedures Document Purpose: To describe the contents of the deviation procedures and to provide guidance on actions to be taken when monitoring results demonstrate that: the programs, standard operating procedures and tasks referenced in the prerequisite programs are not effectively implemented (The standards are not met).
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15.75 $ |
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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 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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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: 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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15.75 $ |
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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: Employees Sanitation and Hygiene Document Purpose: To ensure that all employees in the facility will maintain good personal hygiene practices to ensure food safety.
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31.50 $ |
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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 Document Purpose: The purpose of this procedure is to define the company equipment's design policy to ensure the safety of the food.
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21.00 $ |
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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: Equipments Cleaning and Sanitizing Procedure Document Purpose: The purpose of this document is to prevent food borne illness by ensuring that facility equipments are properly cleaned and sanitized after each use.
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31.50 $ |
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Document Title: Essential Documents Checklist (ICH Parameters) Document Purpose: To specify the documents which should be in place before commencing the Clinical phase of the trial, during the Clinical conduct of the trial, and after completion or termination of the trial. This is to permit evaluation of the conduct of a study and the quality of the data produced. |
84.00 $ |
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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: Facility Maintenance Document Purpose: The purpose of this procedure is to define the company minimum facility maintenance requirements to ensure the safety of the food.
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15.75 $ |
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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: Finished Products Tracking Number (Product Coding) 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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15.75 $ |
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Document Title: Food Deliveries Document Purpose: Is to ensure that the food is fresh and safe when it enters the distribution operation.
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15.75 $ |
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Document Title: Food Transportation and Carriers Document Purpose: The purpose of this document is to prevent food borne illness by ensuring that food temperatures are maintained during transportation and contamination is prevented.
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21.00 $ |
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Document Title: Foreign Materials Control Program Document Purpose: To ensure that the establishment implements documented procedures to control the contamination of product by foreign material.
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15.75 $ |
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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: Hand Washing Document Purpose: The purpose of this procedure is to describe the company minimum hand washing requirements in order to prevent food borne illness by contaminated hands.
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21.00 $ |
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Document Title: Handling a Product Recall Document Purpose: The purpose of this SOP is to describe the processes for withdrawal, or recall of marketed product for quality-related reasons, and to provide information on the recall reporting procedure.
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42.00 $ |
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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: Informed Consent Form Document Purpose: To provide the essential requirements for writing an informed consent form.
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105.00 $ |
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Document Title: Investigational Product Adverse Event Reporting Document Purpose: This SOP is to describe the procedure for reporting clinical trials adverse events.
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52.50 $ |
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Document Title: Investigational Product Recall Document Purpose: The purpose of this SOP is to outline the processes for recovering investigational product supplies from investigational sites and CROs for quality related withdrawals or product recalls.
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63.00 $ |
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Document Title: Investigator Selection Document Purpose: This document is to describe the process for Investigator selection Document Code: CLN-005 Number Of Pages: 2 |
21.00 $ |
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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 Expired and Extended Investigational Supply Document Purpose: To describe the process and responsibilities for managing expired investigational product and, updating product labels with retest/ expiry dating at an investigational site
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21.00 $ |
