SOP for Routine Cleaning Verifictaion by TOC-SSM Method

1.0 OBJECTIVE

To verify the efficacy of the routine cleaning procedure by TOC-SSM method.

2.0 SCOPE

This procedure is applicable for
(a.) Establishment of TOC limits to product wise
(b.) Routine cleaning verification of tablet dosage forms

3.0 RESPONSIBILITY

3.1 Doing: Technical Assistant
3.2 Checking: Executive/Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

5.1 Establishment of TOC limits product wise
5.1.1 Refer the MAR value of the product which is earlier decided on the basis of worst-case product.
5.1.2 Calculate the weight to be taken for the establishment of limit as per following formula.

        MAR value X Av.wt.of tablet
=- ------------------------------------------
              Label claim ( Strength )

5.1.3 Take the calculated weight of tablet granules into sample boat.
5.1.4 Calculate the mean value of corrected carbon (ABSc.) in µcg.
5.1.5 Established the limits for each product.
5.1.6 Prepare the list with the product name, MAR limit and ABSc.
5.2 Routine cleaning verification
5.2.1 Receive the ‘Cleaning test request slip’ along with sampled swab from QA.
5.2.2 Operate the instrument as per S.O.P.
5.2.3 Analyse the sample by putting the swab into sample boat.
5.2.4 Results obtained in µg of absolute carbon.
5.2.5 Write down the results in ‘cleaning test request slip’ along with limit and send it to tablet department.
5.2.6 File the TOC graph along with a copy of ‘Cleaning test request slip’ for the record.

6.0 ABBREVIATIONS

6.1 µg= microgram
6.2 QA= Quality Assurance
6.3 SOP= Standard operating procedure
6.4 Doc.cell= Documentation cell
6.5 ABSc= Absolute carbon
6.6 MAR = Maximum allowable residue.

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