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Objectives of this SOP are listed below –

  1. Define the system of information and control.
  2. To minimize the risk of misinterpretation and errors inherent in oral or casual written
  3. To provide unambiguous procedures to be followed.
  4. To provide confirmation of performance of a task.
  5. To allow calculations to be checked.
  6. And finally to allow tracing of the batch history of any product.


SCOPE:This SOP provides guidelines regarding Good Documentation Practices to be followed by all the authorized employees of company name Who going to prepare, use, issue and store the documents and records.




RESPONSIBILITY:Officers/Executives/HODs of all the departments responsible for preparation, use, issue and storage of the documents and records.




  1. Importance of Documentation

1.1 Good documentation is an essential part of the quality assurance system and as such should be related to all aspects of cG.M.P.


1.2 It defines the specification for all materials and methods and control.

1.3 It ensures that all personnel concerned with manufacture know, what to do? How to do? When to do? Why to do?


1.4 It ensures that authorized persons have all the information necessary to decide whether or not to release a batch of a drug for sale or distribution


1.5 It provides an audit trail that will permit investigations of the history of an defective batch.


  1. Preparation, Issue and Use of Documents:


2.1 Documents should be carefully and logically set out to encourage correct use and easy to check. Documents should contain all necessary, but no superfluous data. Any headings items or spaces on a master document that ceases to be used should be removed at the earliest opportunity.


2.2 Each document should indicate or include:

  • The user’s company or trading name.
  • Purpose and title of document.
  • Document identity number which uniquely identifies the document revision if any.
  • Date of authorization.
  • Date of expiry or review (in case of SOP’s etc.).
  • Signature of authorizing persons and where different, the signature of the person who prepared the document.
  • The distribution list, where copies are distributed
  • Page numbers (and number of total pages).
  • The way in which the document is to be used, and by whom, should be clearly apparent from the document itself.
  • The reason for revision should be documented.
  • Reference used for preparation of the document if any.



2.3 Issued documents should not be hand written. Reproduced of computer printed document should be clear and legible; in the case of batch documents each must be initialed to indicate a verified issue.


2.4 Any correction made in a document should be initialed or signed and dated and the correction should permit the reading of the original information. Where appropriate, the for the correction should be recorded.


2.5 Documents which require the entry of the date or additional information should:

  1. Provide sufficient space for the entry
  2. Allow adequate spacing between entries
  3. Clearly indicate what is to be entered.


Where any issued document required the entry of data or additional information,
entries should be hand written clearly and legibly in permanent ink. If a handwritten
entry is corrected, the correction should permit reading of the original entry and should be initialed by the person making it.


2.6 Where documents bear instructions they should be written in the imperative, i.e. as a direct command as numbered steps. They should be clear, precise, unambiguous and in simple English that the user can understand. Such documents should be readily available to all concerned carrying out instructions.


2.7 Documents should be kept up to date. Any amendments should be formally authorized before the document is used. In the case of permanent amendments, the amended document should be replaced at the earliest opportunity by a newly prepared document and superseded document so marked and filed.


2.8 Master Documents having a direct bearing on product quality should be authorized by the person responsible for Quality Assurance or that person’s delegate as well as by a responsible Production or other relevant Manager.


  1. Storage, Retention and retrieval of Documents and Records:


3.1 Except where legislation require longer retention periods, the complete records pertaining to each batch, including original data such as laboratory note books, should be retained for at least one year after the expiry date of the batch or where there is no expiry date, for six years after the date of manufacturing of the batch. Records of complaints should be held for corresponding period.


3.2 master documents should be properly secured against theft loss and alteration of information.


3.3 Paper or film records should be stored to a restricted access area. Records should be protected from tempering or loss.


3.4 Records may be retained by computer storing system by the procedures and checks should be followed. Such records should be progressively backed up (e.g. daily) and the backup kept at a location remote from the active file.


3.5 All documents should be stored in the department in such a fashion that their retrieval is easy.


3.6 A total list of documents should be made. This list should show –

  1. The name of the document
  2. Location of availability.
  3. Person to be contacted for retrieval.


3.7 Any document on demand, if available should be made available to the demanding authority in reasonable period of time.


3.8 Completed BMR must be always be kept in lock and key under the control of QA.


3.9 Retrieval of any MFR and other important documents should be possible only on proper authorization of QA.


  1. Disposal of Documents:


The expired documents must be destroyed by QA. With proper record and authorization by a suitable method e.g. shredding, burning etc.


  1. Do’s and Don’ts:


5.1 Information recorded should be easy to read (i.e. legible).


5.2 Abbreviated date should be recorded by Date/Month/Year.


5.3 Blue ball pen must be used when completing documents.


5.4 All defined spaces, which are not used, must be completed with N/A dated and signed by          responsible colleague.


5.5 Scrap paper should not be used for recording the data.


5.6 Any document must never be post dated or backdated.


5.7 If any error is found immediately after recording the data, cross out incorrect information with a single line. Enter the correct data near correction and sign.


5.8 Information should be recorded in note book, batch-manufacturing record. Entries of signatures or initials and dates must be made at the same time.


5.9 Do not overwrite any data and do not leave blank in-process sheets, batch manufacturing records logbooks and laboratory notebooks.


5.10 Information should be recorded on the documents concurrent to the activity.


5.11 Corrective fluids or erasable pens should not be used to correct the original information


5.12 Original information should always be entered directly to the applicable document.




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