Module 3 - Strategic case studies in practice

PL 12063/0073

CONFIDENTIAL

In Process Testing and Sampling Manufacture of finished capsules In the manufacture of both the Day and the Night capsules, samples of the finished capsules are taken during manufacture and are checked for average weight. Packing of the capsules into blisters During the packing process throughout the filling run, the operators will be vigilant in ensuring that there is no mixing of the two types of capsule in the capsule hoppers, elevators and bowls. The two types of capsules will be supplied using separate capsule hoppers, elevators and bowls. Capsules will be passed to the filler via a divided feeder such that six Max Strength Cold & Flu Capsules (red/yellow) will fill pockets in one section of the blister and two Max Strength Cold & Flu Night Capsules (light blue/dark blue) will fill pockets in the other section of the same blister. A colour camera capsule detection system will be used to confirm the presence of the correct capsules in each section of the blister following suitable validation of this system in the capsule filling process (see also section 3.2.P.3.5.3). At the start, end and at specified intervals throughout the packing operation, the following tests will be performed: Seal Integrity 10 filled blisters will be tested for seal integrity every 4 hours using Seal Test Equipment. Appearance Every 30 minutes, 10 blisters will be subjected to appearance testing which involves examination for: Correctness and legibility of the on-line embossed batch/date variable data Correctness and visual aspects of the pre-printed blister foil artwork Appearance and uniformity of the seal Correct format of capsules in the blister Any other aspect of the filled blister, which may have an impact on quality. All blisters must comply with the Seal Integrity Test. All visual aspects of the blisters, including the correct format of undamaged capsules in the blister, must be deemed acceptable. A Process Validation Protocol (PVP06-028) is provided (see section 3.2.P.3.5.3) which details the in-process controls during the validation of the filling of the blisters.

3.2.P.3.3.3