1.0 OBJECTIVETo verify the efficacy of the routine cleaning procedure by TOC-SSM method .
2.0 SCOPEThis procedure is applicable for
(a.) Establishment of TOC limits to product wise
(b.) Routine cleaning verification of tablet dosage forms
3.0 RESPONSIBILITY3.1 Doing : Technical Assistant
3.2 Checking : Executive/Manager
4.0 ACCOUNTABILITYHead of the Department
5.1 Establishment of TOC limits product wise5.1.1 Refer the MAR value of product which is earlier decided on the basis of worst case product.
5.1.2 Calculate the weight to be taken for 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 product name, MAR limit and ABSc.
5.2 Routine cleaning verification5.2.1 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 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 copy of ‘Cleaning test request slip’ for record.
6.0 ABBREVIATIONS6.1 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.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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