The The con contr trol ol samp sample le shou should ld be kept kept in thei theirr fin final al pack packag agin ing g and and stor stored ed unde underr the the recommended recommended conditions.
Precautions 1.
Any An y with withdr draw awal al from from the the cont contro roll samp sample le shou should ld be regi regist ster ered ed in the the cont contro roll samp sample le register (Format given below under the heading heading of Format of recording recording ) Procedure 1. QA Chem Chemis istt shou should ld draw draw the the sam sampl ples es at inte interv rval als s of of pac packa kagi ging ng of of the the prod produc uct. t. 2. 3.
4. 5.
Samp Sample les s dra drawn wn at each each inte interv rval al shou should ld be plac placed ed sepa separa rate tely ly in the the pla place ce prov provid ided ed for for the same. Afte Afterr comp comple leti tion on of of pack packin ing g of the the bat batch ch,, pool pool the the sam sampl ples es and and col colle lect ct uni units ts (bl (blis iste ters rs// strips) equivalent equivalent to 200 tablets/capsules tablets/capsules or at least one carton pack as per Annexure –I e.g. For 10’s pack - 20 units, units, For 7’s pack pack - 29 units or for Ecosprin one carton carton of 25 x 14’s The blisters/strips should be collected in over printed cartons. Past Paste e the the “ CONT CONTRO ROL L SA SAMP MPLE LE – NOT FOR FOR SA SALE LE“ “ stic sticke kerr on cart carton on and each each strip/Blister, duly signed and dated.
6.
Keep the control samples on the rack as per location provided in A/c retained sample room. The sample should be kept from left to right direction on the rack.
Dr. Kumar’s Pharmaceuticals # 17-18, INDUSTRIAL AREA, BILASPUR (H.P.) 174001
Department : Quality Assurance Standard Operating Procedure for Preparation of Master Formula
4. 5. 6. 7.
8.
SOP No.Revision no.-
Page no.-3 of 5 Issue dateEffective DateNext Review-
About 120 tablets/ filled capsules shall be collected from all the containers, which hold the compressed tablets/ filled capsules. The collected samples shall be pooled. After sampling, Chemist QA/Officer QA shall ensure that the containers are properly closed and shall affix “SAMPLED” Stamp on the status label. Chemist QA/Officer QA handover the sample to Executive QC along with technical information sheet & register the sample with the batch details & sampling quantity in Core Tablets Inward Register . Executive QC shall keep the samples in drawer labeled as “ Core, Coated tablet & Filled capsules for analysis”.
Acceptance criteria The control samples of each batch should be retained for one year after the expiry of the batch. Frequency After completion of packing of every batch. Reason for revision First Edition Format for recording Control sample register
