Sop for Analysis of different Dosage forms

Different Dosage forms

This Document describes (Standard Operating procedure) Sop for Analysis of different Dosage forms of manufactured products.

Table of Contents

Sop for Analysis of different Dosage forms of manufactured products.

The Purpose of this SOP is to lay down the procedure for Analysis of different Dosage forms of manufactured products.
This procedure is applicable for Analysis of different Dosage forms of manufactured products.

All Quality Control personnel’s shall be responsible to follow and implement this SOP.

The product shall be completely analyzed as per standard or specifications for the sample drawn at intermediate and finished stage.
The extent and the type of testing required to be carried out on the product shall depend on the different dosage forms, and shall be following guidelines.
Sampling and analysis for validation batches shall be carried out as indicated in individual protocol.

1) FOR TABLET:

Dry granules: Loss on drying shall be carried out on the granules of all products before release for lubrication. Test to be done by IPQA
Lubricated granules: Carried out Assay of active content as per Specifications, All content need to carry out before next process.
Core/semi-finished tablets: These shall be tested for physical parameters and disintegration test which are carried out on tablets.
Coated tablets: Only physical parameters shall be checked on the mixed sample taken from various containers of the batch.
Finished pack: Complete analysis shall be carried out as per the in-house specifications/ /Pharmacopeia on the samples collected.

2) FOR CAPSULE :

Blend: Carried out Assay of active content as per Specifications, If contain is more than one active all content need to carried out before next process.
Filled capsules: Only physical parameters shall be checked of received samples.
Finished pack: Complete analysis shall be carried out as per the in-house specifications/Pharmacopeia on the samples collected.

3) FOR OINTMENTS :

Bulk: Carried out pH & Viscosity to proceeds next process.
Final pack: Complete analysis shall be carried out as per the in-house specifications /Pharmacopeia of received samples.

4) TIME LINE FOR RELEASE OF IN-PROCESS & FINISHED PRODUCT

4.1) FOR IN-HOUSE TEST

In-process product Release maximum 3 days after receiving the sample in QC department.
Process validation samples shall be tested as per protocol received. The analysis shall be completed for all validation samples within 30 days.
Finished product Release maximum 30 days for Tablets, Capsules & External preparation.
If any deviation occurred to release within timeline then raise the deviation when observed.