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Prevention and Product Mix Up

Prevention and Product Mix Up

OBJECTIVE:   To lay down the Procedure for prevention of Product mix-up.

SCOPE: This procedure is applicable for the control and prevention of product mix up during and after the manufacturing of the product .

RESPONSIBILITY: QA officer and Production Officer shall be responsible for the follow the procedure mention in this   SOP.

ACCOUNTABILITY: QA Head and Production Head shall be accountable for compliance of this SOP.

ATTACHMENTS: 

Not Applicable

PROCEDURE:

DISPENSING:

Cross-contamination is the contamination of a starting material, intermediate or finished product with another starting material or product

Have adequate segregation of materials products and components to further reduce the risk of cross contamination.

Use Cleaning Status labeling on all equipment and materials used within the manufacturing facility.

Production department shall send the store copy of the dispensing sheet which is attached in the BMR the product to be manufactured/ packed to the Stores.

After receiving the dispensing sheet, officer stores shall arrange for the dispensing of the material as per the dispensing sheet.

Production shall receive the material and follow the below mentioned points for the control and prevention of product mix-up.

Before dispensing the material is crosschecked with the BMR.

During material weighing, required details are mentioned in the dispensing sheet and dispensing material tag and ensure that the containers are properly sealed.

All the material is placed on one pellet at a time.

MANUFACTURING:

After receiving, Production officer check and verify the raw material with raw material requisition attached in BMR.

Manufacture products in a campaign, with the appropriately qualified cleaning processes and checks performed in-between batches to minimize the amount of product changeovers.

Use Cleaning Status labeling on all equipment and materials used within the manufacturing facility.

Ensure that material is issued as per manufacturing order.

Ensure that area is clear of remnants of previous batch.

Ensure that all equipments/ Instruments are clearly identified and labeled.

PACKING:

Ensure that material is issued as per packaging order.

Ensure that area and lines are clear of remnants of previous batch.

Ensure that all equipments, packaging lines are clearly identified and labeled.

All production and IPQA persons handling the product shall follow the entry and exit procedure.

Ensure that the cleaning and operation of machine/equipments are as per relevant SOP.

All the recording at packing is on line and is assured by production and QA person.

Personnel protective equipment (PPE)

Clean body coverings Cleanroom clothing (appropriate for each cleanroom classification)

Appropriate footwear (e.g.: steel-capped shoes and shoe covers), which is provided by the company

Street clothing and shoes must not be worn within GMP areas.

Direct contact should be avoided between the operator and starting materials, primary packing materials and intermediate and finished products.

Cleaning and housekeeping of all areas within a facility should be performed routinely. This includes  floors, ceilings, walls, work surfaces Empty bins regularly

Clean any spills immediately Remove all unnecessary equipment and store appropriately

Labels should be attached to each piece of equipment to clearly state the cleaning status

Do not use cleaning aids such as bristles, brushes and particle-shedding clothes for manual cleaning of equipment

REFERENCES:

In House

ABBREVIATION:

QA    : Quality Assurance

IPQA :  In-Process Quality Assurance

DISTRIBUTION LIST:

Quality Assurance Department

Quality Control Department

Production Department

Engineering & Utility Department

Warehouse Department

HISTORY OF REVISION:

Version  No. Effective Date Reason for Revision
00       – New SOP

 

 

 

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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