Standard operating procedure for retesting of active & excipient raw materials or SOP for retesting of raw materials.
1.0 Purpose
The purpose of this SOP is to develop a standard procedure for retesting of raw materials in pharmaceutical industries to ensure compliance.
2.0 Scope
This SOP for retesting of raw materials is applicable for all the approved active & inactive raw materials.
3.0 Responsibility
3.1 Retest date entry by store officer.
3.2 Retest sample collection by QC assistant.
3.3 Retesting tests performed by QC officer.
3.4 The HOP is responsible for ensuring the implementation of the current SOP.
3.5 Q.A. Officer monitors the compliance of this SOP.
4.0 Procedure
4.1 The store officer shall enter the retest date provided by the manufacturer in computer & approved format on receiving the raw materials (both API & excipients)
4.2 Retest date shall not be more than the provided expiry date of the materials.
4.3 The Raw material officer shall filter out the list of all the materials to be retest in a specific month & send it to the Quality control department at least one week before.
4.4 After receiving the list the QC assistant shall visit the raw material store for sampling.
4.5 Sampling shall be done in the sampling booth as per sampling SOP.
4.6 Cross the previous release label & affix the ‘Under Retest’ label on the container to be sampled.
4.7 After taking the sample the QC assistant shall affix a Sampled label to the container from which sample was taken.
4.8 After sampling of a specific material, the raw material officer shall change the status of material from Released to Under Retesting.
4.9 QC officer shall perform the required test as per SOP.
4.10 If all the retest results are within specifications print out a new release label with updated retest date & affix it to the material container.
4.11 If retest results are not within the specifications affix Rejected label on the container & place it in the rejected cage.
4.12 Change the materials status & updated retest date in the computer as per their status Rejected or Released.
4.13 Retest certificate is provided by the QC manager to the raw material store.
5.0 Abbreviations
5.1 SOP: Standard Operating Procedure
5.2 QA: Quality Assurance
5.3 HOP:Head Of Production.
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