QM: 8.2.4 Monitoring and measurement of product

Introduction

In phrama/biopharma, product realization process is established through rigorous scientific experimentation, optimization, development, validation followed by regulatory review and approval, making them the only consumer product to follow this life cycle. Approved processes are used for production and any change to this state is controlled by change control procedure. Change which may potentially affects the quality, safety and efficacy of the product need to be approved by national regulatory authority before implementation.

Measuring and monitoring of product characteristics is an integral part of pharmaceutical/biopharmaceutical manufacturing process. The quality is not tested into product (by testing final product) but is built in a product through process control, control of starting material, intermediates and finished product. When all the stages of the production process/product meet the predefined requirements (specifications) the final product is accepted as a quality product and released by an authorized person. The production process is performed and controlled as per Standard Operating Procedures and inspection plans. Materials used in production are inspected, sampled and tested as per sampling and testing plan. Records of product realization are maintained in Batch Manufacturing Record and Analytical Reports.

8.2.4

Product Monitoring & Measurement

8.2.4 Monitoring and measurement of product

The company monitors and measures the characteristics of the product to verify that product requirements are fulfilled. This is carried out at appropriates stages of the product realization processes. The process of product realization is charted out in Drug Master File/Master Formulae Record these documents also defined the sampling and inspection points in a process. In-process testing is conducted at defined stages and finished product is tested to ensure it conforms to specification. When appropriate, statistically relevant inspection and sampling plan is utilized. 

Product testing can be divided into three stages:

    a.    Receiving inspections and Testing: All purchased products are subjected to a visual inspection by the receiving staff. Materials used in processing or as part of the product or packaging (RM/PM) is released for use after the samples have been successfully inspected against predefined specifications. Release of materials prior to verification is neither allowed nor practiced. No material is released prior to being verified per requirements and specifications.

    b.   In-process inspection and Testing: In process inspection and testing for manufactured products are in accordance with the prescribed Standard Operating Procedure, inspection and testing plan, Master Formulae Record and specifications. These procedures specify the acceptance criteria, and action to be taken if non-conformity occurs. Where subjective criteria are referenced, the final decision is made by Quality Department. In process inspections and monitoring can also be performed using automated equipments and instruments or statistical process control wherever applicable. Where such methods are used acceptance criteria shall be defined and approved. This stage focus on defect prevention rather than detection.

    c.    Final Inspection and testing: Finished product is subjected to final Quality inspection. Final inspection and testing is performed in accordance to sampling plan and test specifications following approved procedures. These procedures specify the acceptance criteria (which shall include the criteria for validity of test and acceptance limit) and action to be taken if the product fails. Where subjective criteria are referenced, the final decision is made by Quality Department.

Tests are performed by trained and qualified personnel and product is released (for next operation or for market) by authorized person after review of all the requirements.

    d.   Inspection and test records: Records that demonstrate inspection and test results are maintained in accordance with the appropriate procedures. Test results are recorded, reviewed and filed in Analytical Record File by batch number. Wherever applicable the certificate of analysis is prepared (COA). Records are maintained as evidence of conformity with the acceptance criteria. The records include the person(s) performing the inspections and tests and person(s) authorizing the release of the product.

The products are not released until all the required inspections and test have verified that it meets specification and the appropriate records have been generated. Non-conforming products are stored separately from other products.

Shipping of the product does not proceed until planned arrangements have been satisfactorily completed. The organization ensures that documents required by the contract or order to accompany the product are present at delivery and product is protected against loss and deterioration.