Gmp record retention sop

    • What are the retention rules in this SOP?

      The retention rules are separated into broad functional areas within this SOP. Activities may be structured differently in each Local Policing Area, but this should not prevent the application of the rules.

    • What are the retention rules for records?

      Retention rules are for master sets of records only. Duplicate records may be destroyed at any point appropriate to the work of PS. However, heavily annotated records cannot be considered duplicates and must be maintained using the same rules as the master records. 3. Roles and Responsibilities

    • How do you dispose of documentation and samples?

      5.11 Disposal of Documentation and Samples Documents and samples should be destroyed at the end of their appropriate retention period. Disposal of samples must be in accordance with relevant EHS principles. A record of the disposal should be retained. Documents must be disposed of by shredding or incineration.

    • What is the SOP for consistency of response?

      This SOP provides clear direction and procedural instruction to provide a consistency of response in accordance with force policy, however it is recognised that policing is a dynamic profession and the standard response may not be appropriate in every circumstance.

    • [PDF File]5.0 Documentation and Records

      https://info.5y1.org/gmp-record-retention-sop_1_500c95.html

      Schedule for retention and disposition of records 3. Storage and retrieval system of records 4. Person(s) responsible at each level of storage and retrieval for records ... Standard operating procedures (SOPs) Field and laboratory notebooks . ... majority of the documentation referred to in this section can be an electronic record. Retention of ...

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    • Chapter 10. Storage and retention of records and …

      STORAGE AND RETENTION OF RECORDS AND MATERIALS ... SOPs need to be in place for data handling, record retention and good documentation practices and deviation handling etc. 3. Additional considerations for electronic data If a system is required to maintain electronic data, it …

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    • [PDF File]Record Retention Standard Operating Procedure

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      Record Retention Standard Operating Procedure This SOP provides clear direction and procedural instruction to provide a consistency of response in accordance with force policy, however it is recognised that policing is a dynamic profession and the standard response may not be appropriate in every circumstance. In every situation, your decisions and

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    • [PDF File]Annex 4 WHO guidelines for sampling of …

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      The size of a retention sample should be sufficient to allow for at least two confirmatory analyses. In some cases statu- ... inspector should record that the sampled material is the available sample ... • manufacturers in the context of good manufacturing practices (GMP). The samplers need to be adequately trained in the practical aspects of

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    • A WHO guide to good manufacturing practice (GMP) …

      4.1 Standard operating procedures, specifications and master formulae. Descriptive documents give instructions on how to perform a procedure or a study, or give a description of specifications. The instruction type documents are: standard operating procedures (SOP); protocols (for validation studies, stability studies, safety

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    • [PDF File]GlaxoSmithKline Pharmaceuticals Limited Records Retention ...

      https://info.5y1.org/gmp-record-retention-sop_1_39c291.html

      Record Category Description Examples Retention Period as per Proposed India SOP C o m m e n t s GRS001 Administrative Records Documentation relating to routine administrative activities performed by most departments, regardless of function, such as correspondence, agendas, diaries, etc.

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    • [PDF File]1 Purpose 2 Scope and Applicability 3 Definitions

      https://info.5y1.org/gmp-record-retention-sop_1_d33e9a.html

      The records lifecycle is the life span of a record from creation or receipt to its final disposition. 4 Responsibilities 4.1 Archives Management Organization or part of an organization responsible for the retention, safe storage, availability and scheduled disposal of records required for regulatory compliance, legal or other reasons.

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    • [PDF File]Retention and Disposal of GMP Documents and Retention …

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      Disposal of samples must be in accordance with relevant EHS principles. A record of the disposal should be retained. Documents must be disposed of by shredding or incineration. ... Retention and Disposal of GMP Documents and Retention Samples Author: gmpsop.com Subject:

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    • [DOC File]SOP .in

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      Objective. To define the procedure for the preparation, control, and retention of GMP relevant documents. Scope. This standard operating procedure (SOP) is applicable for all departments of Solitaire Pharmacia Pvt. Ltd., Baddi that are concerned with document as defined below-

      gmp record retention requirements

    • APPENDIX B: Example of an Audit Checklist

      Is there control access to the archival facility? Is the environment of the facility monitored and controlled? Is the procedure for archiving records outlined in an SOP? Is the retention time for records stated in the SOP? Is there a method of electronic data archive?

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    • [DOC File]8

      https://info.5y1.org/gmp-record-retention-sop_1_f8d6c5.html

      Record Retention 8-10. DEVICE MASTER RECORD CONTENTS 8-10. Device Specification 8-10. Specific Documents 8-11. Records for In Vitro Diagnostic Products 8-11. QUALITY SYSTEM RECORD DOCUMENTS 8-13. WRITTEN PROCEDURES 8-13. Developing Procedures 8-14. Content of Procedures 8-15. CHANGE CONTROL 8-17. EXHIBITS 8-18

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    • 1

      Stability Lot Retention. Machine Quality Record. QUALITY MANAGEMENT MANUAL. GMP / SOP- SAMPLE RETENTION. Date Issued: 07/01/2008. Page 1 of 2 _____ Revised by: QA Manager Supersedes date: Jan. 2007 Authorized by: General Manager Feb 01 2008:Our company GMP-SOP:1.13 Sample Retention.doc

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    • [DOC File]New Chapter 8 of GMP guide for consultation

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      The checking or testing of reference and/or retention samples should be considered as part of this, and in certain cases, a review of the batch production record should be performed. The need to request a sample of the defective product from the complainant and, where a sample is provided, the need for an appropriate evaluation to be carried out.

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    • [DOC File]SITE FDA INSPECTION PREPARATION CHECKLIST

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      Instructions: Use page one of this document to record information provided by the FDA at the time of initial contact. The remainder of the document should be used to track the progress of the Site FDA Inspection Preparation tasks. Check each item as it is completed and record pertinent comments.

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    • Tier 3 SOP Template

      21 CFR 820.180 GMP/QSR Procedures. 21 CFR 58.190 and 58.195 GLP Procedures. 29 CFR 1910. Other standards as described in QAM-001 “Quality Manual” SOP IT-006 Network Server Backup Operation. SOP SRP-001 Methods for SOP’s. SOP SRP-024 Quality Record Transport Procedures. Internal Revenue Service Regulations. Definitions. GLP - Good ...

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    • SOP No - NIST

      (See GMP 7). Wet-down of pipet and flask. Fill the standard pipet to until water flows from the top tip, then completely drain into an empty vessel. Check for uniform drainage. Touch off the pipet outlet tip against the container wall to remove excess droplets and to establish a constant tip retention volume.

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    • [DOCX File]Guide: GMP checklist for ATMP manufacturers

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      Introduction: GMP checklist for ATMP manufactures is based on Part IV- GMP Requirements for Advanced Therapy Medicinal Products of the EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines and contains specific questions about quality work at the GMP facility with references to the corresponding requirements of the regulations and supporting documents.

      gmp record retention requirements

    • [DOC File]EXAMPLE

      https://info.5y1.org/gmp-record-retention-sop_1_3f7e1e.html

      record retention Product distribution records shall be maintained properly to facilitate location of products that are recalled. These records shall be maintained for a period of time that exceeds shelf life of expected use of product and at least the length of time specified in other applicable regulations concerning records retention which is ...

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