SOP For In-process Sampling of Drug Product

 

1.0              OBJECTIVE:

To lay down the procedure for inspection and in-process sampling (semi-finish & finish sample) of drug products.

2.0              SCOPE:

This SOP is applicable to all the Bulk and Semi-Finished Product batches manufactured in ------------

3.0              RESPONSIBILITY:

3.1              Production personnel responsible for generate the sample intimation and intimate to IPQA/QA personnel.

3.2              In-process Quality Assurance (IPQA) officer responsible for receive intimation and execute sampling process.

4.0              ACCOUNTABILITY:                       

4.1              The accountability for implementation and complies lies upon originating department Head and Q.A. Head.

5.0              PROCEDURE:

5.1              After completion of final blending process production personnel generate the Semi-finish (Bulk) intimation as per Format No.: F/QA-004-01 and intimate to IPQA officer for collecting the sample.

5.2              IPQA officer after receipt of Semi-finish (Bulk) Sample intimation from the Production, then IPQA officer shall be collect the samples from three different layers (locations) (top, middle and bottom) using suitable Sampling Rod & Die and entered in the “Sample Intimation Log” (F/QA-024-01) send composite samples to QC along with duly filled sample intimation slip.

5.3              For exhibit / validation batches the samples collected according to the sampling plan given in protocol by IPQA person at each stage.

5.4              For blend uniformity testing, the samples collected from the blender shall be 1x to 3x of the quantity equivalent to each dose unit.

5.5              Under Test label shall be affixed on containers by IPQA.

5.6              Inspection – The all samples shall be inspected randomly as per BMR/BPR specifications.

5.7              Sampling of In-process semi finished products (Tablets, Capsules, Ointment):

5.7.1        In-process semi finished products can be classified into different categories, based on stages of processing:

5.7.1.1  Powder blend.

5.7.1.2  Core Tablets.

5.7.1.3  Coated Tablets.

5.7.1.4  Filled capsules.

5.7.1.5  Ointment or Externals

5.7.2        Only trained In-process Quality Assurance (IPQA) officer shall withdraw the all in process samples.

5.7.3        Note: Next step shall be carried out only when the result of the In-process semi finished products meets the specified criteria.

5.7.4        Semi-finish for Powder Blend sample:

5.7.4.1  In case of tablets & capsules collect NLT 30 grams of composite sample for QC and other as per validation protocol requirement from the Blender after completion final blending process.

5.7.5        Semi-finish for Core Tablets and Coated Tablets sample:

5.7.5.1  Collect 80 tablets for products that which label claim for active ingredient is less than or equal to 20 mg /Tablets.

5.7.5.2  Collect 60 tablets for products that which label claim for active ingredient are more than 20 mg/Tablet.

5.7.5.3  Collect the sample of tablets from the drums after randomly completion of the process.

5.7.6        Semi-finish for Filled Capsules sample:

5.7.6.1  Collect 80 Capsules for products that which label claim for active ingredient is less than or equal to 20 mg/capsule and

5.7.6.2  Collect 60 Capsules for products that which label claim for active ingredient is more than 20 mg/capsule.

5.7.6.3  Collect the sample of capsules from the drums after randomly completion of the process.

5.7.7        Semi-finish for Ointment or Externals:

5.7.7.1  In case of ointment collect NLT 20 grams of composite sample and send to QC and other as per validation protocol requirement from the Blender after completion final blending process.

5.8              If any Blend powder /Core tablet /Coated tablet stored due to any reason more than 15 days should be resample and send to QC for reanalysis.

5.9              After getting the result the batch can be processed further. If any blend powder /core tablet /coated tablet containing Potassium Clavulanate in the batch and due to any reason store more than 7 days then batch should be resample and send to QC for reanalysis.

5.10          Next step shall be carried out only when the result of the semi-finished products meets the specified criteria.

5.11          The sample shall be then labeled with “SAMPLE FOR ANALYSIS” label having details like Product Name, Batch No., Stage, Batch Size, Mfg. Date, Exp. Date, Sample Quantity, and Sign/Date.

5.12          Then it shall be entered in the “SAMPLE INTIMATION LOG” Format No.: F/QA-024-01 and sent to Quality Control Department.

5.13          The Quality Control Department shall receive the sample and on completion of analysis shall send the results to QA Department in the intimation itself indicating whether the sample complies or not and then the batch is released by QA for next Stage.

            Note:   After receipt Result Semi-Finish (Bulk) Sample Intimation as per Format No.: F/QA-004-01 from the QC by IPQA person. This intimation slip will be attached only with the BMR/BPR.

 

6.0              LSIT OF ANNEXURE AND FORMATS:                            

Sr. No.	Title of Format	Format No.
	Semi-Finish (Bulk) Sample Intimation	F/QA-004-01
	Sample For Analysis	A/QA-004-01

 

7.0              REFERENCE:

7.1              SOP-QA-001

7.2              F/QA-001-01

7.3              F/QA-024-01

7.4              SOP-QA-014

 

8.0              REVISION HISTORY:   

 

Sr. No.	Date	Reason for Revision	Revision No
1.	31/10/2018	New SOP	R0
2.	31/10/2020	Schedule Revision	R1

 

 

9.0     ABBREVIATIONS:

Sr. No	Abbreviations	Details
01	SOP	Standard operating procedure
02	QA	Quality assurance
03	Mfg. Date,	Manufacturing date
04	Exp. Date	Expiry date

 

 

 

 

 

 

 

END OF DOCUMENT