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DRA Book

Drug development notebooks are essential records that document the drug development process in a complete and truthful manner. They are issued to scientists working on projects and contain details of experiments, results, decisions made, and signatures from reviewers. The notebooks are maintained according to standard operating procedures and archived after project completion. Signatures from peers, supervisors, and quality assurance are required to validate the work documented and ensure the records are accurate. Notebooks must record all preformulation trials, manufacturing methods, quality testing, specifications, abnormalities, and failed batches to provide a full history of the development process.

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3K views2 pages

DRA Book

Drug development notebooks are essential records that document the drug development process in a complete and truthful manner. They are issued to scientists working on projects and contain details of experiments, results, decisions made, and signatures from reviewers. The notebooks are maintained according to standard operating procedures and archived after project completion. Signatures from peers, supervisors, and quality assurance are required to validate the work documented and ensure the records are accurate. Notebooks must record all preformulation trials, manufacturing methods, quality testing, specifications, abnormalities, and failed batches to provide a full history of the development process.

Uploaded by

DrGajanan Vaishnav
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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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
days 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 data
4. All manufacturing methods used
5. Equipment used, speeds and times
6. All IPQC
7. All results and observervations
8. All tentative specifications
9. All finished product controls
10. Proposed stability specifications
11. All failed data, and abnormal results.
12. Investigations and conclusions

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