In-process Checks During Manufacturing of Liquid Products
1.0 Objective
To lay down a procedure for in-process checks during manufacturing of oral liquid product.
2.0 Scope
This Standard Operating Procedure is applicable for in-process checks during manufacturing
of liquid to be followed at formulation plants of abc Pvt. Ltd.
3.0 Responsibility
3.1 Officer/Executive Production & QA shall be responsible for in-process checks during manufacturing of liquid.
3.2 Concern department Head shall be responsible for implementation of this SOP.
3.3 Head QA / his designee shall be responsible for compliance of this SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
RH : Relative Humidity
BPCR : Batch Production and Control Record
No. : Number
RLAF : Reverse Laminar Air Flow
API : Active Pharmaceutical Ingredient
QA : Quality Assurance
QC : Quality Control
5.0 Procedure
5.1 QA shall ensure the followings steps before start of any stage of Process:
5.1.1 Gowning procedure shall be followed by the all personnel working in
manufacturing area as per the respective specified SOP.
5.1.2 All the manufacturing area, manufacturing related area and
equipment’s shall be cleaned as per respective SOP.
5.1.3 Temperature and RH shall be with in limit the same should be recorded in the BPCR.
5.1.4 Manufacturing area shall be cleaned and line clearance at every stage
of process has been carried out as per respective SOP.
5.1.5 Equipment Log of all area shall be filled correctly and completely at every stage as per respective SOP.
5.1.6 All the weighing balances shall be calibrated / verified as per respective SOP.
5.1.7 All the Intermediate product containers of area and equipment shall
be identified by status labels as per respective SOP.
5.1.8 Rinse/Swab samples shall be collected by Officer/Executive QA as per
predetermined locations of each equipment as per respective SOP.
5.1.9 Differential pressure of the area shall be within the limit and shall be recorded as per respective SOP.
5.2 Stage: Manufacturing
5.2.1 Ensure the BPCR of running product / batch available online before starting of manufacturing activity.
5.2.2 Ensure and verify all the dispensed materials against Bill of Material in BPCR and dispensing slip.
5.2.3 Ensure that the material is taken for processing of product as per BPCR.
5.2.4 Ensure the compliance of parameters and its recorded in the BPCR.
5.2.5 Addition of raw materials shall be carried out as per procedure written in BPCR in
the presence Officer/Executive QA.
5.2.6 After completion of mixing stage, Officer/Executive QA shall carry out the sampling as per SOP.
5.2.7 After sampling, Officer/Executive QA shall ensure that the containers shall be sealed, closed and labelled.
5.3 Stage: Filling & Sealing
5.3.1 Officer/Executive QA shall check the bulk release & rinse water release from QC and its
report enclosed with respective BPCR.
5.3.2 Officer/Executive QA shall check the liquid bottles for its fill volume, volume variation
and its clarity for any foreign matter.
5.3.3 Officer/Executive QA shall check the bottles physically for any stickiness.
5.3.4 Officer/Executive QA shall check the sealing integrity of bottles by taking its leak test as per respective SOP.
5.4 Stage: Optical Inspection
5.4.1 Officer/Executive QA shall check the inspection of liquid bottles and Record in BPCR.
5.4.2 Officer/Executive QA shall withdraw of finished sample from secondary packing for QC analysis.
5.4.3 Officer/Executive QA shall ensure the completion of On-line documentation in the
BPCR at completion of every stage.
5.4.4 In case, if any discrepancy is observed in the process/ document/ environmental parameters,
Officer/Executive QA shall inform the same immediately to the concerned person/ respective
area In-charge and also to Head QA.
5.4.5 Record the details of In-process checking with green ink in BPCR.
5.5 Stage: Packing
5.5.1 Packing of liquid products shall be done as per respective
6.0 Forms and Records
6.1 None
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Controlled copies – Production, Quality Assurance
8.0 History
| Revision Number | Details For Change |
Reason for Revision |
| 00 | New SOP | NA |
- process validation protocol for methylcobalamin niacinamide and pyridoxine injection
validation protocol of sterility test
sop for Analytical Method Transfer
Protocol for hold time study of sterile garments
sop for swab sampling for validation of clean surfaces
cleaning validation maco and noel calculation formula
sop for performance qualification for analyst
Sop for Validation report for disinfectant efficacy
Sop for Method validation report for bacterial endotoxin test
Sop for method validation microbiology sterility testing
sop for validation report for preservative efficacy test
sop for Protocol cum report for efficacy qualification of uv light
sop for validation protocol for uv light efficacy of dpb & laf
sop for cleaning validation protocol tablet manufacturing equipment
sop for cleaning validation protocol ointment manufacturing equipmentconcurrent process validation for rabeprazole ec and domperidone sr capsules
sop for Validation for cleaning procedure liquid injection
sop for Validation for cleaning procedure dry powder injection
Preparation Approval Control and Distribution of Master Formula Records
calibration policy for equipment and instruments
evaluation Sampling of Raw Materials questionnaire
training evaluation questionnaire
sop for approval of Contract Parties
sop for Operation and Cleaning of Purified Water Generation System
sop for Storage of Standard Weights
-
process validation protocol for methylcobalamin niacinamide and pyridoxine injection
validation protocol of sterility test
sop for Analytical Method Transfer
Protocol for hold time study of sterile garments
sop for swab sampling for validation of clean surfaces
cleaning validation maco and noel calculation formula
sop for performance qualification for analyst
Sop for Validation report for disinfectant efficacy
Sop for Method validation report for bacterial endotoxin test
Sop for method validation microbiology sterility testing
sop for validation report for preservative efficacy test
sop for Protocol cum report for efficacy qualification of uv light
sop for validation protocol for uv light efficacy of dpb & laf
sop for cleaning validation protocol tablet manufacturing equipment
sop for cleaning validation protocol ointment manufacturing equipmentconcurrent process validation for rabeprazole ec and domperidone sr capsules
sop for Validation for cleaning procedure liquid injection
sop for Validation for cleaning procedure dry powder injection
Preparation Approval Control and Distribution of Master Formula Records
calibration policy for equipment and instruments
evaluation Sampling of Raw Materials questionnaire
training evaluation questionnaire
sop for approval of Contract Parties
sop for Operation and Cleaning of Purified Water Generation System
sop for Storage of Standard Weights
sop for Verification of Weighing Balance
-
Sop for Submitting of Leave Application
sop for Accident Management Procedures
sop for Accident Management Procedures
Cleaning and colour coding of Factory Apparel (Clothes)
Job Responsibilities of Key Personnel
sop for Maintenance of Building
Destruction of Batch Production and Control Records BPCR
Procedure for Sampling of Rinse water Swab
Cleaning Validation of Equipment
Measurement and Recording of Temperature and Relative Humid
Sampling of Product at Intermediate Stages
Approval of Overprinting on Packing Material
sop for Procedure for Reprocessing
Preparation and Control of Master Batch Production and Control record
Issuance and Retrieval of Control documents
Calibration Policy for equipment
procedure for batch numbering system for products
sop for Handling of Incident during operation
Procedure for Allocation of Numbers for Machine Equipment
Validation and Qualification Facility System and Equipment
In-process Checks During Packing Operation
Procedure for Issuance of Extra Raw Material Packing Material