SOP for in-process quality checks during manufacturing and packing of drug product
1.0 OBJECTIVE
To describe the procedure for in-process checks during various manufacturing stages and packing of drug products (Tablets/ Capsules).
2.0 SCOPE
The scope of this standard operating procedure (SOP) is to perform In-process checks during the various manufacturing stages and packing of the drug product (Tablet/ Capsules), e.g., Dispensing, granulation, compression, capsule filling, coating, overprinting, packing, etc. by in-process quality assurance person at [your company name].
3.0 RESPONSIBILITY
3.1 Head Quality Assurance (QA) is responsible to
3.1.1 Ensure implementation and compliance of SOP.
3.1.2 Carry out investigation in case of any failure.
3.1.3 Ensure corrective action and preventive action to be taken.
3.2 QA person
3.2.1 Collect the samples in the required quantity.
3.2.2 Collect the samples at a defined frequency.
3.2.3 Perform in-process checks as per the procedure.
4.0 PROCEDURE
4.1 Dispensing of raw material
4.1.1 Before commencing dispensing, the QA person will ensure the updation of logbooks.
4.1.2 QA person will fill up the checklist for material during dispensing as per Annexure-II. Following checks will be performed such as “area status” between the time of dispensing of two materials of different A.R.No. “material status,” i.e., Approved, rejected, under test or under hold, “material code, “ i.e., item code and Analytical report No. (A.R.No.) with Bill Of Material (BOM) /Issue Slip & expiry date of ingredients against the identification label and dispensing tags after dispensing of material is over.
4.1.3 QA person will also check the retest period/retest date for each material.
4.1.4 QA person will verify the quantity dispensed and put the sign and date in checked by the column of Batch Manufacturing Record (BMR).
4.1.5 Dispensing of packing Material
4.1.6 Warehouse person will intimate to QA before dispensing of packing material.
4.1.7 QA person will verify the material to be dispensed against the Bill of Material (BOM) and verify against the pasted label and put sign and date in verified by columns of Batch packing record (BPR).
4.2 Granulation.
4.2 Granulation.
4.2.1 Sampling procedure shall be performed by Inprocess Quality Assurance (IPQA) person according to the current version of SOP on “Sampling of Granules (Blends)/Uncoated tablets/Coated Tablets/Finished Product” and performs the test as per specification in IPQA / Q.C. Laboratory and subsequently enter the values in the controlled separate worksheet.
4.2.2 The second IPQA person verifies the worksheet for all the tests given in the worksheet should comply and fall within the acceptance limit (as per specification) or receive the blend report from QC in case of validation and verify by the QA person. After that IPQA person will approve the blend for compression and record the same in BMR by putting the sign and date in the space provided in BMR and file the worksheet/report in the respective BMR.
4.3 Compression.
4.3.1 QA person will collect the required amount of tablets from the compression machine from each side, i.e. (LHS & RHS), perform the physical parameters test, and record the observation in the BMR.
4.3.2 Sampling procedure shall be performed according to the current version of SOP on “Sampling of Granules (Blends)/Uncoated tablets/Coated Tablets/Finished Product.”
4.3.3 The test will be performed at the initial stage and the frequency per BMR.
4.3.4 The various In-Process test performed are as under:
1. Appearance
2. Average weight
3. Diameter
4. Thickness
5. Hardness
6. Disintegration time
7. Friability
8. Uniformity of weight (Balance printout to be attached with BMR)
4.3.5 All the tests shall be performed separately for the LHS and RHS sides of the compression machine during in-process.
4.3.6 IPQA person analyses the composite sample for physical parameters and records the same in the analytical worksheet. Then, the second IPQA person checks and verify the worksheet and files it in the respective BMR.
4.3.7 After receiving the release report from QC, the QA person will verify the report. All the tests given in the report should comply and fall within the acceptance limit (as per specification). After that IPQA person will approve the compressed tablets for the next process (Coating / Packing) and record the same in BMR by putting the sign and date in the space provided and file the report/worksheet in the respective BMR.
4.4 Capsule Filling.
4.4 Capsule Filling.
4.4.1 QA person will collect the required amount of capsules from the filling machine, perform the physical parameters test, and record the observation in the BMR.
4.4.2 Sampling procedure shall be performed according to the current version of SOP on “Sampling of Granules (Blends)/Uncoated tablets/Coated Tablets/Finished Product.”
4.4.3 The test will be performed at the initial stage, and the frequency as per BMR.
4.4.4 The various In-Process test performed are as under:
1. Description
2. Average weight of filled capsules
3. Average fill weight of capsules
4. Uniformity of weight of capsules (Balance printout to be attached with BMR)
5. Weight of 20 capsules
6. Locking Length
7. Disintegration time
4.4.5 All the tests shall be performed per the frequency mentioned in BMR.
4.4.6 IPQA person analyses the sample for physical parameters and records the same in BMR.
4.4.7 After receiving the release report from QC, the QA person will verify the information. All the tests given in the report should comply and fall within the acceptance limit (as per specification); after that IPQA person will approve the capsules for the next process (Packing) and record the same in BMR by putting the sign and date in the space provided and file the report in the respective BMR.
4.5 Coating.
4.5.1 QA person will collect the required amount of tablets after completion of coating from the coating pan or from all the containers, lot wise.
4.5.2 Sampling procedure shall be performed according to the current version of SOP on “Sampling of Granules (Blends)/Uncoated tablets/Coated Tablets/Finished Product.”
4.5.3 The various in-process test performed are as under
1. Appearance
2. Friability
3. Average weight
4. Disintegration time
5. Uniformity of weight (Balance printout to be attached with BMR)
4.5.4 IPQA person analyses the composite sample for physical parameters as per specification and records the same in the analytical worksheet. Then, the second IPQA person checks and verifies that all the tests given in the worksheet should comply and fall within the acceptance limit (as per specification). After that, the IPQA person will approve the coated tablets for the next process (Packing) and record the same in BMR by putting the sign and date in the space provided and filing the worksheet in the respective BMR.
4.6 Overprinting.
4.6.1 On receipt of the coded packing material specimen duly signed by the packing operator, the packing supervisor, the QA person will check the identity of the packing material detail from BPR.
4.6.2 QA person verifies the following coded details against BPR, i.e., B. No., Mfg. Date, Exp. Date, MRP, Manufacturing License Number, Physician Sample Not To Be Sold, or Any other information such as “ For Institutional use,” other details such as pack style ex. 60X10X2X14 TABS etc.
4.6.3 Each packing material, i.e., blister, show boxes, box label, is coded after pre-approval from the QA person for stereo details.
4.6.4 Approval regarding the coding or stereo details may be taken
(i) At the start of the new batch, coding approval shall be taken by signing the details by the packing operator, packing supervisor, and QA person.
(ii) After any breakdown in the coding process, approval shall be taken by signing the details by the packing operator, packing supervisor, and QA person.
(iii) At the start of the new shift, approval shall be taken by signing the details by the packing operator and packing supervisor only.
4.6.5 The price of the unit pack should be verified with the latest price list available.
4.6.6 The B.No., Mfg. Date, Exp. Date should be verified with BMR.
4.6.7 In the case of a physician sample, the phrase “PHYSICIAN SAMPLE NOT TO BE SOLD” should be overprinted in red ink.
4.6.8 There should be no MRP overprinted on the pack of physician samples.
4.6.9 QA person will approve by signing and putting the date in the space provided in BPR and on the specimen.
4.7 Primary packing / Packing operation.
4.7 Primary packing / Packing operation.
4.7.1 Primary packing.
4.7.1.1 QA person will ensure the approved label on the tablet container.
4.7.1.2 Verify the performance/working of the camera at the start of the new batch/product and at every four hours frequency during In-Process checks by putting the sign and date in columns of BPR.
4.7.1.3 QA person will perform a leak test for the blisters at the start and at every four hours frequently during in-process checks.
4.7.1.4 During performing leak test as per frequency, the test will be performed by production, and QA will verify the same, and the result will be recorded in the space provided in BPR.
4.7.1.5 QA person will approve after checking the recoverable tablets generated during the de-blistering operation and put the sign and date in the space provided in the BPR.
4.7.2 Packing operation.
4.7.2.1 QA person will carry out the in-process checks as per the checkpoints of BPR.
4.7.2.2 QA person will verify the daily packing slip prepared by the production person with the shipper label and BPR before transferring to the Finished Goods Store (FGS).
4.7.2.3 Ensure the destruction of the stereo after completing the batch and putting the sign and date in BPR.
NOTE: If the QA person observes any abnormal observation (Non-conformances) during in-process quality checks, the QA shall inform the production and QA head using the “Observation sheet.” The production head shall provide corrective and preventive action, which is to be finally approved by the head of QA.
5.0 ANNEXURE (S):
Annexure – I: Checklist for Raw Material Dispensing
Checklist for Raw Material Dispensing
Product Name:
Date of dispensing:
Batch size:
B. No. :
Manufacturing Date:
Expiry Date:
QA Person:
Dispensing person:
Details in Table
Sr. No
Name of item
Area status (Ok/ Not ok)
Ensure Label Details (Checked by/ Date)
Material status
Material code
A.R.No
Expiry of ingredients
Dispensing Tag (Ok/ Not ok)