In-process Checks During Dispensing and Manufacturing of Tablets and Capsules

1.0 Objective
To lay down a procedure for In-process checks during dispensing and manufacturing

of tablets and capsules.
2.0 Scope
This Standard Operating Procedure is applicable for In-process checks during dispensing

and manufacturing of tablets and capsules to be followed at formulation plants of abc Pvt. Ltd.
3.0 Responsibility
3.1 Officer / Executive Warehouse shall be responsible for dispensing of raw materials.
3.2 Officer / Executive Production shall be responsible for checking of dispensed raw materials.
3.3 Officer / Executive In-process Quality Assurance shall be responsible for verification of dispensed

raw materials and in-process checks during manufacturing of Tablets and Capsules.
3.4 Concern department head and Head QA / his designee shall be responsible for compliance of this SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
BPCR : Batch Production & Control Record
RLAF : Reverse Laminar Air Flow
API : Active Pharmaceutical Ingredient
RH : Relative Humidity
LOD : Loss on dry
QA : Quality Assurance
No. : Number
MRN : Material requisition note
5.0 Procedure
5.1 Ensure the following points before starting the dispensing activity.
5.1.1 Gowning procedure shall be followed by the personnel working in dispensing area as per respective SOP.
5.1.2 Temperature and RH shall be recorded as per respective SOP.
5.1.3 All the weighing balances shall be calibrated as per respective SOP.
5.1.4 Differential pressure of the area shall be within the limit and recorded as per respective SOP.
5.1.5 Check the values of moisture content and assay of each active ingredient against the A.R.No.
5.1.6 Ensure the excipients shall be dispensed first, followed by actives pharmaceutical ingredients (API).
5.1.7 Ensure that double poly bags shall be used for dispensed material.
5.1.8 Ensure separate cleaned scoops shall be used for different excipients and API.
5.1.9 Check for QC approved (Green) status label and the re-testing date on the container
5.1.10 Check for the item description and item code on the approved label against the BPCR.
5.1.11 Check that the GRN No. on the approved label. Further check the under test label also matches correctly.
5.1.12 Check that every container/ bag/ package shall be tightly closed before and after dispensing.
5.1.13 In case of loose containers, check for the weight as per the “Loose container” label.
5.1.14 Ensure the right capacity balance shall be used to weigh as per the required accuracy of net weight.
5.1.15 Ensure that the gloves used for dispensing of one active are not used for any other material.
5.2 Dispensing of Raw Materials
5.2.1 Ensure the BPCR of product / batch shall be in place before start of dispensing activity.
5.2.2 Following points shall be check before start of any batch dispensing:
5.2.2.1 RLAF shall be ‘ON’ before 30minutes of dispensing.
5.2.2.2 All the material shall have approved label.
5.2.3 Officer / Executive Warehouse shall dispense one batch at a time.
5.2.4 Ensure the dispensing of all API and ‘Excipients’ under red line of defined Reverse laminar Air Flow.
5.2.5 Ensure at a time only one container shall be taken under RLAF.
5.2.6 Ensure the proper entry in BPCR for dispensed raw materials.
5.3 Officer/Executive QA shall ensure the following points before start of any stage of manufacturing process:
5.3.1 All the Equipment shall be cleaned as per respective SOP.
5.3.2 Temperature and RH shall be recorded in the BPCR as per respective SOP.
5.3.3 Manufacturing Area shall be cleaned and Line Clearance at every stage of manufacturing

shall be carried out as per respective SOP.
5.3.4 Equipment Log of the area shall be filled correctly and completely at every stage as per respective SOP.
5.3.5 All the weighing balances shall be calibrated as per respective SOP.
5.3.6 All the Intermediate product containers of area and equipment shall be identified by the status labels.
5.3.7 Swab samples shall be collected by Officer/Executive QA as per predetermined locations of each

equipment as per respective SOP.
5.3.8 Differential pressure of the area shall be within the limit and shall be recorded as per respective SOP.
5.4 Stage: Sifting / Milling
5.4.1 Ensure the BPCR of running product/batch shall be in place before starting of sifting/ milling activity.
5.4.2 Verification of dispensed material against Bill of Material.
5.4.3 Check the material taken for processing of product shall be as per BPCR and shall be processed as per BPCR.
5.4.4 Ensure the compliance of parameters and its record in the BPCR.
5.4.5 Mesh size of sieve & screen shall be specified in the BPCR.
5.4.6 Integrity of sieve and screen before and after use.
5.5 Stage: Granulation and Blending
5.5.1 Officer/Executive QA shall ensure that the processing shall be carried out in accordance with the BPCR.
5.5.2 LOD of the granules.
5.5.3 Mesh size of sieve and screen as specified in the BPCR.
5.5.4 Integrity of sieve before and after use.
5.5.5 Officer/Executive QA shall perform the sampling of lubricated granules as per respective SOP of sampling.
5.5.6 After sampling, Officer/Executive QA shall check the containers shall be sealed, closed and labelled.
5.6 Stage: Compression
5.6.1 Officer/Executive QA shall ensure that blend shall be released for compression.
5.6.2 Officer/Executive QA shall check the data of In-process parameters (description, average weight,

weight variation, hardness, thickness, friability and disintegration test) of tablets for compliance,

which shall be carried out by production as per the frequency mentioned in the BPCR.
5.6.3 Officer/Executive QA shall check all the parameters as per the frequency mentioned in BPCR

and record in the BPCR in green ink.
5.6.4 Officer/Executive QA shall perform the semi-finished product sampling of uncoated tablets as

per respective SOP of sampling.
5.6.5 After sampling, Officer/Executive QA shall also ensure that the containers shall be sealed,

closed and labelled.
5.7 Stage: Coating
5.7.1 Officer/Executive QA shall verify the details of dispensed coating material against BPCR.
5.7.2 Officer/Executive QA shall check data of In-process parameters (description, Average weight,

disintegration test and Thickness) of coated tablets for compliance which shall be carried out by Production.
5.7.3 Officer/Executive QA shall perform the sampling of In-process Product of coated tablets as per respective SOP.
5.7.4 After sampling, Officer/Executive QA shall also ensure that the containers shall be sealed, closed and labelled.
5.8 Stage: Capsulation
5.8.1 Officer/Executive QA shall check that batch shall be released for capsulation as per BPCR.
5.8.2 Officer/Executive QA shall ensure the processing of product shall be in accordance with the BPCR.
5.8.3 Officer/Executive QA shall check the data of In-process parameters (description, Average weight,

weight variation, net content, locking length and disintegration test) of Capsules for compliance,

which shall be carried out by Production.
5.8.4 Officer/Executive QA shall check above all the parameters as per the frequency and record

in the BPCR in green ink.
5.8.5 Officer/Executive QA shall carry out the sampling of the In-process Product as per Respective SOP.
5.8.6 After sampling, Officer/Executive QA shall ensure the containers shall be sealed, closed and labelled.
5.9 Inspection
5.9.1 Officer/Executive QA shall check the uncoated tablets / coated tablets / capsule for appearance

and record in BPCR.
5.9.2 Officer/Executive QA ensure that inspection of product shall be carried out in accordance with the BPCR.
5.9.3 After completion of inspection, Officer/Executive QA shall also ensure that the containers shall

be sealed, closed and labelled.
5.10 Officer/Executive QA shall ensure the completion of on-line documentation in the BPCR at

completion of every manufacturing stage.
5.11 If any discrepancy is observed in the process / document / environmental parameters at any stage,

Officer/Executive QA shall inform the same immediately to the concerned

person / respective area In-charge and also to Head QA.
5.12 Record the details of In-process checking with green ink in a checklist

attach in BPCR of the respective product.
6.0 Forms and Records
6.1 None
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Controlled copies – Quality Assurance and Production
8.0 History