In post detail are given of Inprocess Checking During Manufacturing to maintained quality of all pharmaceuticals products.
Inprocess Checking During Manufacturing SOPs
To maintain and improve the quality of drug we need to Inprocess Checking During Manufacturing as per guidelines so that the potency of drugs increases.
Purpose:
This SOP “Inprocess Checking During Manufacturing” is designed to check the good manufacturing practices and Quality of all products during manufacturing (CGMP).
Scope:
This SOP “Inprocess Checking During Manufacturing” covers the all the Inprocess Checking During Manufacturing of solid Dosage forms that is Tablet and Capsule.
Responsibilities:
a. It is the responsibility of all Production Pharmacists, Production Staff and Q.A officers to follow this SOP during Product Manufacturing.
b. It is the responsibility of Quality Assurance Manager and Production Manager to ensure that this SOP is followed in its entirety, reviewed and update as necessary.
Procedure:
1- Check that the powder after final mix is transferred into clean containers.
2- Check that the container is properly labeled, indicating date, product name, Batch no., Batch Size and stage.
3- Check that the container bear quality Control “APPROVED” slips where applicable for the further processing.
4- Check that the compression or encapsulation machine is thoroughly cleaned and proper exhaust pipes are connected to the machine.
5- Check that the encapsulation or compression machine bear proper label indicating, Date, Product Name, Batch No., Batch Size, &and Q.C. approved slips.
6- Check that the products are manufactured in their specific designated areas.
7- Check for the compliance of operators for wearing specific dresses and protection where applicable.
8- Check the compressed tablets for:
i) Mottling/ Spotting
ii) Chipping
iii) Sticking
iv) Edging
v) Color Formation
vi) Capping double impression.
vii) Cracked tablets
viii) Color Variation
ix) Av. Wt. of 10 tablets and individual weights.
x) Thickness of tablet
xi) Hardness of tablet
xii) Friability
xiii) Disintegration
Check the coated Tablets For:
i) Coating Uniformity
ii) Color variation
iii) Polishing
iv) Broken tablet
v) Weight uniformity
9- Check Filled Capsules For:
i) Dented or pressed capsule
ii) Proper closing of top and bottom shell (locking)
iii) Av. Wt. and individual weight of 10 capsules
iv) Check temp. of the filling area
v) Check humidity of the filling area
10- Check that the “process control sheets” are being maintained. Check and then make the entries in the process control sheets for the following after every 30 minutes.
a) Av. Wt. of 10 tablets / Capsules
b) Thickness of tablet
c) Hardness of tablet
Also perform individual weights of 10 tablets / capsules at the start, after lunch break and evening tea break.Make entries in the process control sheets.
11- Check that the compressed tablets, coated tablets or filled capsules are transferred into clean containers.
12- Check that the containers are properly labeled indicating date, Product name, Batch No., Batch size and stage.
13- Check that the humidity and temperature of the Press or encapsulation Area is in compliance with standard specification.