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Standard Operating Procedure Title: Retest Dating of Raw materials 5.3.2. The Quality Assurance Manager or the Laboratory Manager must be advised immediately of any test during the re-examination.

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Retest Dates are assigned to products for which long term shelf life has not been fully established and to neat reference materials to ensure the continued collection of data. Retest dates are assigned to new products and to products which are continuing on stability testing.

Typically, for new chemical entity APIs stability studies will support an initial retest period of 12-36 months. The retest period can be formally extended over time using data generated from mature stability study programs.

5.9 Sampling procedure for retesting : For raw materials under retest, sampling shall be performed as per above mentioned sampling procedure and collected from each available container in a polythene bag to make the composite sample. Re-test sample shall be labeled as per , retest sampled label.

Retest period: The period of time during which the drug substance is expected to remain within its specification and, therefore, can be used in the manufacture of a given drug product, provided that the drug substance has been stored under the defined conditions.

The Retest Date for an excipient is the date indicated by the supplier after which the excipient should be re-evaluated to ensure continued compliance with appropriate specifications. An excipient retest date may be extended based upon appropriate testing.

5.2 Retest due date shall not be more than the expiry date of the raw material. If the expiry date is less then assign the retest date of 1 year or half the period as stated in Annexure I & II whichever is less for that particular material.

Retest date API or any Raw materials is calculated from the date of previous analysis. It's frequency is generally 6 months to 1 year based on stability characteristics of that API or Raw material at the recommended storage conditions.

5.7 Sampling preparation Check the details on the MATERIAL RECEIVING REPORT and enter the details in computer for UNDER TEST labels as follow. ... Prepare and send the sample withdrawal slip to the Raw material store for the quantity of material to be sampled.

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© Copyright 1997-2025
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232