• In a pharmaceutical or healthcare GMP environment, implementation of Good documentation practices is very much required as it is directly affecting the product quality, safety, efficacy. If any document related to products is poorly documented (does not give the original picture) then the manufacturer can be negatively impacted during a regulatory inspection and impact patient safety.

Basics of Good Documentation Practices

To meet the current regulatory and industry expectation, it is necessary that all the documentation follow good documentation practices when it affects:

  • Any stage of product manufacturing, packaging, analysis, storage, and distribution.
  • Product quality, safety, efficacy, purity, and strength.
  • Validated condition of any process, equipment & facility
  • Any registered dossier

As per USFDA 21 CFR 211.188 Batch production and control record, it is stated that:

Batch production and control records shall be prepared for each batch of drug product produced and shall include complete information relating to the production and control of each batch. These records shall include:

(a) An accurate reproduction of the appropriate master production or control record, checked for accuracy, dated, and signed;

(b) Documentation that each significant step in the manufacture, processing, packing, or holding of the batch was accomplished, including:

Following are the basic rules of good documentation practices:

  • The document should be written in a manner that prevents errors.

  • If any error that should be correct by a single strike with the signature/ date and justification remark so that another person can go through justification and see the striking text. If space constraints then put a symbol (* star, #- Hash, etc.) and write correct details on the same page where is space available.
  • All the documents should be reviewed by a competent person to ensure its accuracy and correctness and approved by quality.
  • Legible handwritten entries.
  • Always use permanent ink.
  • Do not leave any blank space. Always write “Not applicable” with signature and date where no entry required.
  • Do not use ditto marks ( ” ) to indicate as above.
  • Always made direct entries rather than write on some rough paper and finally transcribe on other documents.
  • Do not use an eraser to remove the original details.

How to control unauthorized changes  in electronic record & correct the entries

All 21 CFR  compliant software has an audit trail option and every change in the record can be tracked by referring the audit trail so below instructions should be followed while handling any software.

  1. Any addition/deletion or correction in all the electronic records should be justified with a comment.
  2. Any addition/ deletion or correction in the electronic record/software should be reviewed by a competent reviewer and approved.
  3. Never use unauthorized access mean never use other person login credentials.
  4. Audit trail should be reviewed at a defined frequency to identify and gaps and their impact.
  5. There should be access privilege form to provide the defined access to software and it should be approved by Quality Assurance.
  6. To avoid any unauthorized changes in software, administrator rights should be available with independent function.

Effective implementation of good documentation practices (GDP)

For the implementation of good documentation practices in the GMP environment, a well-written policy or procedure on Good Documentation Practices is required which have detailed examples of wrong entry/ wrong practices and have an example “how to correct them”. It is better if an album of all examples should in-place so that during training all examples can be seen to the all relevant people involved in the GMP activities because we all know visual communication is better than any other communication. 

Regular and frequent training on “Good Documentation Practices procedure” to all relevant people is required and there should be an evaluation or effectiveness check tools should be in place to continuously monitor its effectiveness. See more features

 

References

21 CFR 211.188- Batch production and control record Sub-part J Record and report