1.0 PURPOSE:
To provide a written procedure for collection of swab for cleaning validation.
2.0 SCOPE:
Applicable to sample from hard to clean area of cleaned equipments.
3.0 RESPONSIBILITY:
Executive Manufacturing, Executive QA, Assistant Manager QA.
4.0 ACCOUNTABILITY:
Manager Quality Assurance.
5.0 DEFINITIONS:
Nil
6.0 PROCEDURE:
6.1 Check the area / part of the equipment which is hard to clean.
6.2 Select 4 x 4 square inch area of the hard surface to clean.
6.3 Swab the marked area using Readymade Swab in four direction as shown below
6.4 Collect the swab sample as per the sampling plan.
6.5 Collect the swab in clean glass bottle labeled properly.
7.0 REFERENCES:
Nil
8.0 ENCLOSURES:
Nil
9.0 ABBREVIATION:
9.1 QA : Quality Assurance
validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality attributes
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2 comments:
Wow! Amazing blog, i like it. If you can feel free, you can visit autoclaves
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