Q.1. Write a short note on drug development notebooks

Pharmaceutical drug development notebooks are essential records of what was done in drug development program. They have a complete and truthful record of what was observed and how technical decisions were taken. Typically they are 100 to 200 pages hardbound notebooks suitable for using in laboratory environment.

Issue and control of the laboratory notebooks is responsibility of documentation group. The documentation group comes under corporate quality assurance department (CQA). When a scientist is assigned a project, he gets a product (drug) development notebook issued on his name. After the project is complete, the notebook is returned to documentation cell (doc cell) and they archive it.

There is an elaborate SOP for issue, maintenance and archiving of product development notebooks. A junior scientist working on a project has to obtain following signatures after each day’s work.

1. Checked by: This signature is usually done by a peer scientist working in the same area. The signature signifies that the work was indeed done and the concerned scientist did the records meticulously.

2. Reviewed by: This signature is done by the group leader. The records as well as conclusions are reviewed well and inferences highlighted. Future course of action is discussed and documented.

Following signatures are taken weekly during preformulation/ formulation and monthly during stability

3. Authorized by: This signature is done by the F&D head. A meeting is called with group leader and concerned scientist. The results and progress are discussed and then signatures made.

4. CQA countersign: The CQA person would check all the records. The raw material labels should be pasted on LHS page. All weighing, sifting, mixing, granulation, drying, lubrication, compression coating labels, and IPQC printouts should be pasted. Everything that can be documented with proof must be preserved. A reserve sample of the latest stage of the trial must be made available by the scientist. CQA person should check some of the IPQC parameters to judge truthfulness of the records.

All preformulation and formulation trials should be recorded. A general rule is “No product was ever developed without a number of reject lots”. All the failures must be truthfully recorded. Key data are:

1. All ingredient lot numbers and expiry dates.2. Active and excipient sources (supplier and batch numbers)3. All preformulation data4. All manufacturing methods used5. Equipment used, speeds and times6. All IPQC7. All results and observervations8. All tentative specifications9. All finished product controls10. Proposed stability specifications11. All failed data, and abnormal results.12. Investigations and conclusions