1.0 PURPOSE:
1.1 It is established to assure quality of Product at each and every step.
2.0 SCOPE:
2.1 It is applicable to Quality Assurance Department.
3.0 RESPONSIBILITIES AND AUTHORITIES:
3.1 Manager Quality Assurances.
3.2 Assistant Manager Quality Assurance.
3.3 Quality Assurance Officer.
3.4 Quality Assurance Assist.
4.0 PROCEDURE :
4.1 GRANULATION/MIXING
On Receiving “Request for sample” Sample will be taken from the Mixer
where the whole batch should be present. The amount of sample should be
sufficient for 3 tests or per Q.C requirement.
4.2 SYRUP /SUSPENSION (Bulk solution)
On receiving “Request for sample” Sample will be taken after recirculation of 15 to 100 liters during mixing stage from the out let of container and total volume of bulk syrup/suspension should be checked before sampling.
4.3 COMPRESSED TABLETS.
During the regular monitoring of compression, Q.A Officer collects 10 tablets on every visit and at the end of compression that collective sample should be submitted to Q.C.
4.4 COATED TABLETS
From coating section sample should be taken from each and every pan (10-20 tablets according to batch size) and at the end of coating that collective Sample should be submitted to Q.C
4.5 ENCAPSULATION:
During the regular inspection of capsule filling section, collect 5-10 capsules (according to batch size/no of dies) on each visit and at the end of filling that collective sample should be submitted to Q.C.
4.6 DRY INJECTION
During the filling of dry injection collect 5-10 vials (according to batch size) on every visit and at the end of filling, sample should be submitted to Q.C.
4.7 AMPOULES
At the end of autoclavation take 5-10 Ampoules from each and every tray and submit the collective sample to Q.C.
5. RECORD REQUIRED
The following record shall be generated and managed in accordance with the procedure for control of company quality records:
| Required Record | Form Reference No |
| Sampled Slip | QF/057/01 |
| Under test Slip | QF/059/01 |
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