Documentation by bandaya

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									DOCUMENTATION




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  CONTENT OF PRESENTATION
1. Introduction
    Objective
    Purpose of documentation
2. Quality System Documentation
    Tiers of documentation
    Quality Manual
    Quality Procedures
    Work Instructions
    Quality records
3. Format of documents
4. How to create good documentation system
5. Manufacturing documents


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INTRODUCTION




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     A reliable evidence for GMP compliance.

Quality by design is the only solution to overcome
the quality-related complaints in an organisation.
An essential element of quality assurance is good
             documentation practices.

The system of documentation devised or adopted
 should have as its main objective to establish,
monitor, and record “quality” for all aspects of the
production, quality control and quality assurance

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         OBJECTIVES
1. To review general requirements
   for documents.

2. To review specific requirements
   for each document.

3. To give general guidance how to
   create good documentation
   system.



                                     5
                 PURPOSE
 Clearly written documentation prevents errors
  that may arise in oral or casually written
  communication

 It provides assurance that quality related
  activities are carried out exactly the way they
  have been planned and approved

 The achievement of conformity and quality
  improvement


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                PURPOSE
 Purpose of documentation :

    To ensure that there are specifications for
     all materials and methods of manufacture
     and control
    Employees know what to do
    Responsibilities and authorities are
     identified
    Ensure that authorized persons have all
     information necessary for release
    Provide audit trail
    Forms the basis for improvement

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 QUALITY SYSTEM
DOCUMENTATION




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                  QUALITY MANUAL
The strategic document that outlines the organization’s system
of providing quality assurance to achieve customer satisfaction.
                        Objectives :
                         Describe the quality system structure
            Quality      Declare the quality policy and organization
            Manual        goal
                                    how the organization meets
                         Describe Content of quality manual : the
            Quality       quality goal
                                    The quality policy declaration
          Procedures
                                    The goal of quality;
          Supporting
                                    The organisational structure
      Documents or Work               including responsibility and
         Instructions                 authority of each key personnel
                                    Procedures, instructions and
                                      resources for implementing the
                                      quality management.
                                   User :
       Quality Records
                                    All personnel in the organization
                                    Another parties, auditors, and
                                      customers
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     QUALITY STANDARD PROCEDURES
The tactical document that outlines the activities or operations
of the organization in implementing the stated quality policies.
                       Objectives :
                       Describe detail explanation how activities should be
             Quality
                       done, controlled and recorded in implementing the
             Manual    definite policy
                                  Standard Operation Procedures explains:
                                   What the process is and its purpose
            Quality                Where activity is operating
          Procedures               Who is responsible for every activity
                                   When activity is completed, sequential
          Supporting                 of the activities, frequency, etc.
      Documents or Work            How activity can be finished follow the
         Instructions                work instruction design or other
                                     reference documents
                                   Reference to the other relevant
       Quality Records               documents
                               User :
                                All personnel who set up and run the
                                 processes                               10
               WORK INSTRUCTIONS
The operational document containing instructions specifying
 how the activities are performed or products are accepted.
                        Objectives :
                         It is an instruction document, step by step for
                          guideline to execute the daily activity or
         Quality          operation for personnel in every function
         Manual          It is used departmentally, every task or every
                          line. Content of work instructions :
         Quality                 Detailed explanation of instructions to
       Procedures                  finish the job, detailed handling of
                                   method, equipment and machine
      Supporting                 Related to the technical matters with
     Documents or
    Work Instructions
                                   stressing for operation, inspection &
                                   testing.
                               User :
    Quality Records             All personnel who operates the certain
                                 task
                               Format :
                                Worksheet, sample, checklist           11
                 S.O.P. versus W.I.
QUALITY PROCEDURE/SOP            WORKING INSTRUCTION
  Process oriented               Task oriented
  Describe step of procedure     Describe detail instruction
  Supporting the Quality         Operation guidance
   Manual                         Dedicated to explain special
  Explain general description     task, method, or technique
   on certain process and give     which should be done to
   systematic action to ensure     achieve target quality
   product quality                Instruction guidance which
  Procedure guideline which       dedicated for certain
   involve several departments     department or section only
   and/or sections                During implementation can
  During implementation need      stand alone
   other supported documents      Guidance at operational level
  Guideline at organization
   level
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                     QUALITY RECORDS
Quality Records, including charts and data pertaining to design,
  inspection, testing, survey, audit, review or related results,
 should be maintained as important evidence to demonstrate:

                                effectivity of the Quality System
           Quality               Implementation;
           Manual
                                that products and services have been
                                 developed and delivered appropriately
            Quality
          Procedures             with the requirements.

          Supporting           All Quality Records should be :
      Documents or Work         legible and clear;
         Instructions           dated;
                                readily identifiable and retrievable;
                                carry authorization status;
       Quality Records
                                retained for a designated period;
                                protected from damage and
                                   deterioration while storage.
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     HOW TO CREATE A
GOOD DOCUMENTATION SYSTEM




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                  DOCUMENT
1. Document is :
    A complete history of each batch from starting
       materials to finished products
    A record activities for :
        • maintenance
        • storage
        • quality control
        • primary distribution
        • specific matter related to GMP
2. Documents should be designed, prepared, reviewed and
   distributed with care.
3. All documentation must be organized into files which
   must be maintained for a specified period of time.

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          CONTENT OF DOCUMENT
What should be written in the document:

• Name of document
• Name of company, department or division of the
    maker
•   Document number
•   Page and number of pages of document
•   Number of revision
•   Date of approved
•   Name and signature of the person who prepared the
    document
•   Names and signatures of the person who reviewed
    and person approved the document
•   Body of document
•   Document receiver
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       NUMBERING SYSTEM

 Every document should have a number
  from the Control Division.

 The numbering system should be
  accomplished for easy retrieval and
  control of the document.




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      DOCUMENT CORRECTION
When a wrong entry on document is made,
the following actions must be carried out:
 Draw a line across the original entry (to
  preserve original entry)
 The new entry should be written close to
  original entry
 Correction must be initialed & dated
  computerized : - password
               - dedicated person



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           DOCUMENT CONTROL
• Documents should be dated and authorized
    approved, signed and dated by appropriate
      authorized persons
    no document should be changed without
      authorization
• All document records should be completed as the
  process proceeds.
• Distribution list of documents should be recorded
• Obsolete documents should be :
    taken from users , based on distribution list
    marked “obsolete”, archived
• Create a list of running documents , centralized .
• Use only updated documents
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      DISTRIBUTION DOCUMENT
   Distribution of documents should be the up-
    to-date documents

   Copy of documents should be distributed to
    relevant parties
   The list of distribution should be made
   Document Data Control Division or QC can
    distribute the document
   Main document should be received by
    Production and Quality Control Department
   Supporting document is distributed to
    related division only                         20
        REVISION & RENEWAL
   Should be made periodically, or if needed
   Obsolete documents should be retrieved
    from all relevant parties and its original
    copy should be archived
   The date of revision should be stated in the
    new documents
   Every revision should be approved by
    authorized person



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        RECORD KEEPING RULES
             “Do Not” Rules

   DO NOT scribble out mistakes (obscures entry)
   DO NOT write correct entries over incorrect
    entries (writing over obscures original entries)
   DO NOT forget to enter all required info
   DO NOT forget to initial and write date of entry
   DO NOT use colored ink/pencil
   DO NOT leave mistakes uncorrected (check your
    entries)

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MANUFACTURING
DOCUMENTS



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                 TYPE OF GMP DOCUMENTS
                                      QUALITY MANUAL


                                               S.O.P.


                                                                                         Equipment Status
         Master production Specification/ Testing Work Protocol Identity/                Material Status
              document       Standard     Method          (WP)          Label            Product Status
       Master Formula            Raw & packaging material
Master Prod. Procedure           Bulk                  Validation Protocol              Report

Master Pack. Procedure            Finished product          Sampling record
                                                            Testing result record and report
                                                            Microbial and particle monitoring record
              Batch Production Record                       Stability test record
              Return Product Handling Record
              Recall Record
              Product Destruction Record                Note :
              Product Complaint Record                  •Blue    : WI (standard, specification & procedure)
              Distribution Record                       •Red     : record

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