Procedure for Inprocess Monitoring and Control

1.0	PURPOSE To insure that in process parameter are in control and set parameter are being followed consistently..
2.0	SCOPE This procedure is applicable to all dosage form at Psychotropics India Limited.
3.0	RESPONSIBILITY IPQA Chemist
4.0	ACCOUNTABILITY  Head Quality Assurance
5.0	PROCEDURE
5.1 5.2 5.3 5.4        5.5 5.6 5.7 5.8 5.9 5.10 5.11 5.12 5.13 5.14 5.15 5.16 5.17 5.18 5.19 5.20 5.21 5.22 5.23	B   Check the cleanliness of the area /section. 5.2  Check the clothing of workmen. 5.3  Check the machine log & status label.        Check that all the equipment, vessel are cleaned before use and bear status tag.        Check the RH and temperature is within required limit and being recorded by production persons.                 Check that all the containers/bags bear the material/Product identification Label.                Check that the raw material received at shop floor bear material/Product identification label, verify the quantity as per related BPR.        Calibrate IPQA Instrument as per stated frequency.        Operate the IPQA instrument as per SOP.        Check the manufacturing activity is being recorded in BPR online.        Check Weight variation, tablet hardness, diameter, filled volume, filled powder weight etc. as per stated frequency in BPR.        Check that all the container/Bags of intermediate bulk, semi finished product bear product, process stage status        tag and quantified (Refer BPR).        Check The in process parameter i.e. uniformity of weight, Disintegration time, Friability test, volume as per acceptance criteria given in annexure I.        Check the printed and unprinted packing material as per packing order and verify the quantity (Refer BPR).        Check the coding details w.r.t. batch no. , Mfg date, exp, Date,(ref. BPR) and MRP.        Check the coding details on strip, blister, Label, unit carton, multicarton, sachets etc. is proper, clearly legible, smudgy, overlap coding is not allowed.        Check leak test for bottle/Strip/blister/Sachet and record.              Check that the strip and blister, bottle, jars, sachets and leaflet or any other literature being placed properly in unit carton/multicarton/shipper (ref. BPR packing instruction).        Check and collect control sample from the running belt intermittently.        Check that the unit carton/multicarton/bottle/jars being placed properly in serially no. and labeled shipper              ( Ref. BPR Packing Operation).        Check that the finally packed shipper are being placed properly in serially no. and labeled shipper. (Ref. BPR Packing Instruction).        Check that the finally packed shippers are being placed on plastic pallets.               If any discrepancies observed in view of above, inform to the production chemist /production Incharge in writing on deviation and corrective action from and inform head QA.
6.0	REFERENCES     NIL

7.0

ANNEXURES

Annexure No.	Title of Annexure	Format No.
Annexure I	ACCEPTANCE CRITERIA FOR UNIFORMITY OF WEIGHT (MASSES) AND FILLED VOLUME	QA/005/F01-00

8.0	ABBREVIATIONS

Abbreviations						Full Forms
SOP						Standard Operating Procedure
QA						Quality Assurance
IPQA						In process Quality Assurance
BPR						Batch Processing Record
9.0	DISTRIBUTION
Master Copy							Head Quality Assurance Department
Controlled office Copy No. 1							Head Quality Assurance Deptt.
10.0		REVISION HISTORY
S.No.			Revision No.	Effective Date	Reason for Revision			Details of Change	Authorized By (sign & Date)

                                   

Annexure I

ACCEPTANCE CRITERIA FOR UNIFORMITY OF WEIGHT (MASSES)

 AND FILLED VOLUME

Pharmaceuticals Forms	Sample Size	Average Wt.	Percentage Deviation
			IP	BP	USP	In house Specification
Tablet Uncoated & film Coated	20 tablet	1) 80 mg or less	10	10	1) 10 % up to 130 mg	8%
		2) More Than 80 mg & less than 250 mg	7.5	7.5	2) 7.5 %  130 mg to 324 mg	5.5 %
		3) more than 250 mg	5	5	2) 5 %  for  325 mg or more	3%
Passaries	20	All masses	9			7%
Oral Liquid & suspension	10 units	50 ml or less	9			7%
		More than 50 ml and NMT 200 ml	4.5		……………	3%
		More than 200 ml	3			2%