QM: 7.5.3 Identification and Traceability

Introduction

In pharmaceutical and bio-pharmaceutical industry the traceability is an indicator of product quality as the quality of finished product is influenced by the raw materials used for manufacturing. Traceability shall be demonstrable in forward as well as backward direction. Similar traceability and identification shall be demonstrated in sampling for monitoring and measurement activities.

Supplier ↔ Raw Material ↔ Finished Product

The requirement of traceability is not only important during product realization but also extends to product marketing and distribution. This traceability has been emphasized by all regulatory bodies to be used during an event of quality failure identified post marketing.

7.5.3

Identification & Traceability

7.5.3 Identification and Traceability

The organization has implemented a documented procedure detailing identification & traceability system starting from receipt of raw material and usage in product realization process and final delivery of the product to the customer. These procedures include but are not limited to, incoming purchased items incorporated into the product realization process, in process components, environmental conditions, outsourced components (if any), finished products through the customer, returned products and in addition, to identify the product status with respect to established monitoring and measurement requirements and personnel responsible for processing and verification of products in accordance with the requirements of these standards and the regulatory statutes.

Unique identification of product is controlled and recorded throughout the product realization process by the organization.

Material is identified at various stages of the production process in the following ways: appropriate paperwork (i.e. purchase order), part number identification and labeling (i.e. tested labels, release label). Standard part numbers are assigned to identify released raw material, buffers and solutions, intermediates and finished product.

Following every inspection or test, products are identified to indicate whether they have passed or failed the inspection. This is to prevent nonconforming product from being used or dispatched.

Finished products are serial numbered according to a standardized system. This serial number is used as a means of tracing product to customer. Finished product is stored under controlled conditions in a designated area.

Recalled products are also identified according to product recall procedure and conforming products are segregated from the non-conforming ones. Returned products are stored in a designated area segregated from other products and are properly identified to prevent mix-ups with other products.

Products status is identified with respect to monitoring and measurement requirements by sticking labels defined in quality control procedures and only product that has passed the required inspection and tests is released.

Batch records show the entire traceability and identification of the material used and is traceable to other documents such as purchase orders, GRN & MRN numbers, raw material testing and release records, part numbers, raw material dispensing record, stocks, product testing and release reports, dispatch and distribution records.

GRN: Goods Receipt Note

MRN: Material Receipt Note