1.0 OBJECTIVETo clearly lay down procedure for handling and testing of various samples.
2.0 SCOPEThis procedure is applicable to various samples such as MISCELLENEOUS, VALIDATION & STABILITY SAMPLES for analysis at QC.
3.0 RESPONSIBILITY3.1 Doing : Tech. Asst./Executive
3.2 Checking : Executive /Asst. Manager /Manager
4.0 ACCOUNTABILITYHead of the Department
5.0 PROCEDURE5.1 On receipt of various sample along with inprocess sample test request slip or various correspondence
From various sites, Q.C will give Q.C REPORT No. as per below. X0Y/000Z
For sample received from VALIDATION allot numbering where X= VA
For sample received from MISC. (Other than insulin) allot numbering where X= MIS
For sample received from STABILITY numbering where X= STB
0Y= Year of sample receipt i.e = 01 for year 2001, 05 for year 2005 etc.
000Z= serial number staring from 0001….
5.2 Make the entry respectively in inprocess register with following details.
A. Sr. No.
B. Batch No.
C. Q.C. A.R. No.
D. Mfg. Date
E. Exp. Date
F. Batch Size
G. Date of Receipt
5.3 Distribute samples along with testing slip.
5.4 After completion of entry, put the sample in to "UNDER TEST SAMPLE" tray .
5.5 Quality control incharge/Executive shall distribute the sample along with intimation slip or IC to the chemical section, instrument section & microbiology section for respective analysis.
5.6 Chemist shall analyse the sample as per respective method of analysis & specification and record the results in testing sheet.
5.7 On completion of testing, submit the report to QC incharge/Executive for checking.
5.8 Quality control incharge /Executive shall check the results of chemical, instrumental and microbiological testing.
5.9 Sign the report.
5.10 Quality control incharge/Executive enter the results into respective inprocess entry register.
5.11 After completion of entry, Quality control incharge /Executive shall convey the result to respective department.
5.12 In absence of responsible person, Technical Assistant shall convey the results to production department along with inprocess sample test request slip .
5.13 After completion of testing, destroy the sample as per SOP.
5.14 File the report in to respective file
6.0 ABBREVIATIONS6.1 Q.C = Quality control
6.2 Q.C. A.R.No. = Quality control analytical report number
6.3 Sr.No. = Serial no.
6.4 Mfg. Date = Manufacturing date
6.5 Exp. Date = Expity date
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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