SOP for Hard Gelatin Capsules
Empty hard gelatin capsules are very sensitive materials used in pharmaceutical companies to manufacture capsules. Empty hard gelatin capsules are very hygroscopic and heat-sensitive which can damage a very slight change in temperature and moisture. Therefore, to preserve them safe from such adverse effects proper SOP for hard gelatin capsules is followed throughout the whole storage and manufacturing process.
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SOP for Hard Gelatin Capsules for sampling and testing
Objective: To lay down a procedure for the Sampling & Testing of hard gelatin capsules.
Scope: The procedure of this SOP shall be applicable to the Quality Control Department of XYZ Pharma
Responsibility: Quality Control Chemist
Accountability: Quality Control Manager
Abbreviations :
S.O.P.: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
Procedure for Hard Gelatin Capsules for sampling and testing :
In the whole process of SOP for hard gelatin capsules three major steps are performed (i) Sampling of hard gelatin capsules (ii) Inspection of hard gelatin capsules, and (iii) testing of hard gelating capsules. Every step is discussed in a detailed manner step by step below:
Sampling of Hard gelatin capsules:
Sampling is to be done by the Quality Control Department. The number of capsules to be sampled will depend on the acceptance quality levels (AQLs) for critical, major, and minor defects, which have been worked out and agreed upon with the suppliers.
Inspection of Hard gelatin capsules:
The samples of capsules are to be inspected for the following:
Appearance in comparison with approved reference samples-check for cracks, dents, distortion, etc.
Color in comparison with standard specification.
Legibility and quality of the print (if any) in comparison with approved reference samples.
Self-locking ability on closing the two halves of the capsule.
Dimensions comprising body length, cap length, body diameter, cap diameter, unclosed and closed joined lengths.
The smoothness of separation of unclosed capsules.
Classification of defects into-
Critical defects such as uncut cap/body, split cap/body, holes, uneven cuts, rough edges, etc.
Major defects comprise dimensions outside the specified limits.
Minor defects such as slightly dented ends, loose cap/body, small bubbles, specks, locked capsules, etc.
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Testing of Hard gelatin capsules:
Samples of the capsules are also be analyzed for the following tests:
Moisture was determined as a loss in weight on drying the shells at 105°C. (Ref. Pharmacopoeia method).
The weight of shells was determined on a random sample of 100 capsules.
Disintegration time- by the pharmacopeia method.
Machine trials on at least 1000 capsules to assess their likely behavior on the capsule-filling machines.
Other tests such as total microbial count as per pharmacopeia.
Other tests are described in the pharmacopeia.
Note: SOP for hard gelatin capsules does not replace the instruction given in the IP monograph for hard gelatin capsules required tests.
