Good Documentation Practices

nirvesh400

 

  • OBJECTIVE:

To lay down a procedure to describe the steps to be followed for good documentation practices; and ensure that each personnel receives clear and detailed description of the relevant job assignment to minimize the risk of misinterpretation and error.

  • SCOPE:

This SOP is applicable to all the documents at

  • RESPONSIBILITY:

Concerned staff shall be responsible to follow the procedure mentioned in this SOP.

  • ACCOUNTABILITY :

Concerned Department Head and QA Head shall be accountable for compliance of the procedure mentioned in this SOP.

5.0       ATTACHMENTS :

            Not applicable

  • PROCEDURE :
    • Principle: Good Documentation constitutes an essential part of the Quality Assurance system and is related to all aspects of GMP.
    • Mention time in hours in documents. For example afternoon 1:30 PM; write as 13:30 hours. Change the date after 24:00 hours.
    • Write date in the following manner

DD/MM/YY or YYYY

Where,     DD indicates date

MM indicates month

YY or YYYY indicates year

For example, write 1st September 2019 as 01/09/19

  • Sign all master documents and control documents using blue ink ball pen only.
  • Enter information in records, logs and documents using blue ink ball pen only for all employees, except IPQA. Do not use pencil for any entries or recording of data.
  • IPQA using the black ink ball pen for recording of data in process control during manufacturing and packing activity.
  • Do not overwrite to correct any error on a document. Strictly avoid the use of white ink to correct any error on a document. To correct any error on a document, strike off the error with a single line in such a manner that the original entry is readable. Write the corrected entry close to the original entry, sign and date. Where appropriate, record the reason for alteration.
  • Design and prepare documents in an orderly fashion and in accordance to the standards in such a way that they are easy to check.
  • Appropriate and authorized persons must approve documents. Sign all documents with same signatures as done in the specimen signature register
  • Follow the applicable change control procedure for changes in documents. If documents are required to be discontinued handle the same through change control
  • Review documents regularly according to their defined review period and keep them up-to date (Refer:
  • Where documents require the entry of data, make entries in clear, legible, indelible handwriting. Provide sufficient space for such entries.
  • Where space is void, cross it with a single line across the void space in such a manner that no entries can be made at later stage and write NA with date & sign.
  • Complete the record at the time of each action is taken and in such a way that all significant activities concerning the manufacture of medicinal products are traceable.
  • Compile all the pages of records and documents along with necessary attachments in a chronological order in the file.
  • Reproduced documents must be clear and legible. The reproduction of working documents from master documents must not allow any error to be introduced through the reproduction process.
  • Maintain records for the distribution of documents.
  • Protect documents against accidental and malicious damage. Store documentation and associated information in a safe and secure manner.
  • REFERENCES:

None

  • ABBREVIATIONS:

SOP: Standard  Operating procedure

QA: Quality Assurance

GMP: Good Documentation Practice

NA: Not Applicable

  • DISTRIBUTION LIST :

Quality Assurance

Quality Control

Production

Engineering

Warehouse

Human Resource & Administration

10.0     HISTORY OF REVISION:

Version No. Effective Date Reason for Revision

 

SOPs