QM: 7.5.5 Preservation of product

7.5.5

Preservation of Product

7.5.5 Preservation of product

The company preserves the conformity of the product during internal processing and delivery to the customer. The systems are designed to address the identification, handling, packaging, storage, preservation and delivery requirements of our in-process and final product.

Identification: The products at different stages of processing are identified as per point 7.5.3.

Handling and preservation: Production is responsible for product handling and preservation; and in particular for ensuring that containers holding products are suitable and are in good condition (this includes containers closure systems, pallets, platforms etc.), that the equipments used for internal transportation of products is well maintained and is properly operated (this includes transport trolleys, fork lifters, lift trucks, loaders and other vehicles), and that products are adequately protected during production and storage. Methods and precautions for handling hazardous materials (biological, chemical etc.) are part of Standard Operating Procedure. Warehouse is responsible for storage of materials such as raw materials and finished product under the specified conditions. Personnel are trained for handling procedures.

Packaging: Procedures are in place for packaging of the materials (intermediate and finished product) where such requirements are necessary for storage and transportation. Wherever the packaging is performed the process of packaging is qualified and validated before selecting the method/material of packaging. The records of such validations are maintained. The process of packaging is then defined in a standard operating procedure/work/packaging instruction. Packaging is done as primary packaging, secondary packaging, tertiary packaging or special packaging so as to prevent damage from vibration, shock, abrasion, corrosion, humidity, temperature, or any other conditions occurring during handling, storage and shipping as per requirements. Packaging and labeling are production processes and are controlled and defined. Final packaging for shipping of release product is a warehouse function and is controlled and defined.

Storage: Defined storage areas (stock rooms and storage, staging, and holding areas) are designed for product to prevent damage or deterioration of the product and meet the storage specifications. These areas are maintained and controlled by the department which is responsible for the particular processing stage. Limited shelf life materials are issued on a “first in, first out basis”. Records of appropriate storage conditions are maintained. Procedures and/or work instructions are established for control of all the products.

In general raw materials are stored in their shipping container in warehouse stores with designated stock location (segregated and identified) under appropriate environmental conditions. Intermediates and finished product prior to release are stored in production store rooms with designated stock location under appropriate environmental conditions. Released finished product ready for shipping is stored in warehouse with designated stock location (segregated and identified) under appropriate environmental conditions.

Delivery: The Company utilizes company owned as well as sub-contracted transportation firm for product transportation and delivery. Sub-contractors are approved and reevaluated periodically as per the supplier qualification procedure and list of approved sub-contractors is maintained. Product being prepared for shipping shall pass the final release criteria. Before materials are dispatched, person authorized verifies that the shipment contains the same products and quantities as specified in the shipping/purchase order and the packaging and labeling confirms to in-house requirements, customer and/or carrier requirements. Products are delivered to the customers in a manner that prevents damage and conforms to legal and customer requirements. Distribution records are maintained identifying the consignee name and address, date shipped, product quantity and control numbers (batch/lot numbers) along with mode of transportation in order to maintain traceability and facilitate and corrective action post marketing.

QM: 7.5.4 Customer Property

Introduction

The organization can come across customer property which can be:

Information: Confidential document, proprietary information, plans & layouts, drawings, confidential information such as supplier details, market strategies, business plans etc.

Material: Starting material, intermediate, drug product, drug substance or any other materials which belong to customer but are within the company premises or control such as in-transit, intermediate warehouse or stores.

The standard states that, ‘The organization shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product’.

Requirements of the clause become more important in contract manufacturing or job work scenario.

7.5.4

Customer Property

7.5.4 Customer Property

Customer materials are received and inspected following the same procedure that applies to the purchased products. In the event the supplied product fails receiving inspection, or is not suitable for any other reason, the customer is contacted.

Labeling, storage, handling and preservation of customer supplied product follow the same procedures that apply to purchase products.

Customer software, documents, and other intellectual property are protected to same extent as would internal documents of similar content, unless there are contractual requirements for specific measures to protect customer’s intellectual property.

Wherever specified special handling instructions for customers take precedent over the company’s standard procedures.

Customers are immediately informed in the events of loss, damage, deterioration or, or unsuitability of their products. Records of such events are maintained.