PharmaState Is Official Media Partner For DUPHAT 2020. Click the banner to explore more...spot_imgspot_imgspot_img

Formats for change control , deviation & categorization of changes.

-

Excerpt

1) Do not retain this form and forward to the next after completion of review.
2) Put N/A where not applicable.
3) Attach an additional sheet if required as annexure.
4) Please specify the details in case of “others”.
Name

Excerpt

Where UPD stands for Unplanned Deviation & PD stands for Planned Deviation,
XXX stands for Dept. Code, for ex. QA, QC, PRD, ADM, WH etc.
NNN stands for sequential no. of change control
YY stands for last two digits for the current year, for ex. 19 for 2019

Excerpt

RA: Regulatory Affairs (RA) approvals are required for changes to process filed in DMF. So in
case if there is no submission then QA – Head is authorized to sign in place of RA.

For any Feedback or suggestion, mail at: info@pharmastate.com

PharmaState Blog
This is a platform for people working in the pharmaceuticals industry for Discussions, Jobs, News updates, Professional Profile display space and company business pages. PharmaState DNA is having four pillars: Quality, Transparency, Innovation & Benchmarks.

Share this article

Recent posts

Popular categories

Leave a Reply

Recent comments

Business Alnavedic on History of Indian Pharma Industry
Ahmed Mohamed Elkhodragy on MACO Calculation
Jennifer Osunde on DEFECTS IN UNCOATED TABLETS
Vinod on DEVIATION
Sunil Kumar M on SITE ACCEPTANCE TEST (SAT)
Khalid on IQ Protocol
Khalid on IQ Protocol
Nagabooshanam on Calibration of Reactor
PharmaState Blog on SOP for Sampling
Swapnil Khodake on TOOLING FOR TABLETING
%d bloggers like this: