SOP for Manufacturing In process Control for Manufacturing In-Process Control is essential to ensure the quality and consistency of products during the manufacturing process. These procedures help monitor and control critical parameters at various stages of production.

Purpose

To describe procedures for manufacturing in process control. Clearly state the purpose of the SOP, which is to establish guidelines and procedures for the implementation of in-process controls to monitor and maintain the quality of products during manufacturing.

Scope

This SOP applies to all in process manufacturing control. Define the scope of the SOP, specifying the manufacturing processes and stages where in-process controls are applicable.

Responsibilities

1. It is the responsibility of QAIP and Assistant QAIP to follow this SOP as it is written
2. It is the responsibility of QA manager to make certain that this SOP is being followed in its entirety, review and update as necessary
3. Clearly outline the responsibilities of individuals and departments involved in implementing and monitoring in-process controls, including roles such as Production Operators, Quality Control personnel, and Manufacturing Supervisors.

Definitions

1. In process control: To control and monitor  in process manufacturing to ensure all processes  conform to established  specifications .This include environment monitoring of the production area
2. BPR: Batch Processing Record
3. PRD: Production department

Materials & Equipments

SOP for Manufacturing In process Control

Safety Considerations

SOP for Manufacturing In process Control

Flow Diagram

SOP for Manufacturing In process Control

Procedure

In process control in manufacturing area involves the following steps

Line clearance

Before start of manufacturing operation, QAIP verifies cleaning of the area and other parameters written in the Pre-Check Control Sheet section of the BPR (See Annex – 1)

Equipment cleaning verification

1. Before manufacturing equipment start, production officer inform QAIP to verify cleaning of the equipment
2. QAIP physically verifies cleaning of equipment, check the cleaning logbook and issue label “Cleaned & Ready For Use” (See the label 1)
3. Verification of critical manufacturing steps
4. QAIP verifies critical manufacturing processes as outlined in various section of BPR
5. QAIP verify correctness and accuracy of data recorded by production staff

Area monitoring

1. All area parameters including the Daily Cleaning Report
2. Daily Disinfectant Mopping Weekly Cleaning Report Monthly Sanitation Record and Daily Hygiene Report as per SOP for Cleaning of Sterile Area must be monitor by QAIP.
3. QAIP monitors various production sections are properly labeled with the status of operation as per general regulations of that area

Verification of yield calculation

QAIP verifies calculation of yield at all stages of manufacturing to determine wastage of product .If wastage is determined to be more than 2%, the case must be investigated by production manager

Labeling Verification

1. QAIP verifies all manufacturing equipments are properly labeled
2. QAIP verifies containers of product at in process stage are properly labeled with status of processing. i.e., Released, Quarantined, Production Hold etc.

Equipment Calibration SOP for Manufacturing In process Control

1. QAIP monitors all manufacturing processes should are performed on calibrated equipment
2. QAIP randomly check equipment operational log book for timely data entry. Data should be enters at the time of equipment operation

Dispensing in process control

1. QAIP Verifies the weight of the dispensed raw materials as per weight recorded in BPR and sign the printed slip of the dispensed raw materials
2. Check containers of the dispensed raw materials are properly identified and labeled as per SOP
3. QAIP checks the cabins for following parameters
4. Raw materials for same product and batch number should be placed in the same cabinet per SOP
5. Each cabinet must be labeled as per SOP
6. QAIP verifies dispensed raw materials is used within one weeks from the date the material was dispensed
7. QAIP ensures material dispensing is done for one product at the time. No simultaneous dispensing for different product is allowed
8. NOTE:   In case of Water for Injection BFS Ampoules, dispensing of ingredients is not required.

Solution preparation in process control

1. During solution preparation, QAIP monitors processes as per written instruction in BPR.
2. QAIP verifies final volume of liquid preparation before transferring to filling area
3. Blow Fill Sealing in process control
4. QAIP monitors the adjustment of filling machine / blow, fill, sealing machine according to specification recorded in BPR.
5. During filling of BFS bottle / ampoules / screw caps QAIP randomly perform weight variation as per SOP.
6. QAIP and production officer keep record of testing on “Filling Record Sheet” after every one hour randomly as per SOP.
7. If any parameters such as gross weight / fill volume of BFS bottle / ampoules / screw caps is out of limit, QAIP stop the operation until results   are adjusted according to BPR.

Glass ampoule filling in process control

NOTE: In case of glass ampoules, washing, drying and sterilization of empty glass ampoules is also performed

1. During filling of glass ampoules QAIP randomly measures volume variation, seal integrity, length of ampoule as per SOP (QA/SOP/IP/0000)
2. If parameter such as fill volume, seal integrity, length of glass ampoule is out of limit, QAIP stop the operation until results   are adjusted according to BPR

Required Documents

• SOP for Inprocess sampling
• SOP for Hygiene
• SOP for Sanitation
• SOP for Reprocessing
• General regulations in dispensing area
• General regulation in compression
• SOP for Weight Determination of Tablets
• SOP for Determination of Hardness, Diameter and Thickness of Tablets
• SOP for Thickness Determination of Tablets
• SOP for Performance of Friability Test
• General regulation for Capsule Section
• SOP for Operation and Internal Calibration of Electronic Balance
• SOP for Manufacturing In process Control