QM: 7 Product Realization (7.1 Planning)

Product Realization

Introduction

Product realization is the term used to describe the work that the organization goes through to develop, manufacture, and deliver the finished goods or services. An effective Quality Management System (QMS) includes a comprehensive approach to evolve from the product concept to the finished product.

The clause states that the organization shall plan and develop the processes needed for product realization.

Product realization planning includes the following:

Definition and evaluation of production/service processes

Development of suitable and capable processes (process development)

Identification of special processes and consideration of associated risks and consequences (risk assessment)

Development and implementation of appropriate process control measures (critical control points, critical control parameters, process validation)

Setting quality parameters of product at different stages (specifications of starting material, intermediates, drug substance and drug product)

Development and implementation of appropriate testing methods (testing method validation)

Development of instructions (where applicable) and training for process personnel (SOP and Training)

Identification of the records required to demonstrate product/process quality (quality records)

Processes for product realization can be developed through design and development (clause 7.3).

ICH Q8 and FDA Process validation document provides a standard guidance for product realization in pharma/bio-pharma products.

In phrama/biopharma, development of processes for product realization is a result of through rigorous scientific experimentation, optimization, development, validation, regulatory review and approval, which makes them the only consumer product to follow such life cycle. Approved processes are used for production which ensures state of control and any change to this state is managed through change control procedure. If change is suspected to affects the quality, safety and efficacy of the product, the change need to be approved by the regulatory authority before implementation. Any innovation and improvement in the processes shall also be reviewed and approved by the regulatory authority before implementation.

Requirements of production process, process variables control strategy, parameter control, quality of starting material, intermediates, drug substance, drug product along with other information (clinical performance of the product) are compiled in regulatory dossier (Drug Master File) and reviewed and approved by the regulatory authorities before approving the commercial manufacturing of the product. This is applicable to all products.

Once the processes are developed, next level of planning is required for manufacturing and delivery of the product to the customer in a structured and controlled manner to meet requirements at acceptable business risk,  within resource and schedule constraints. The organization shall plan the product realization at this stage through controls, approvals, monitoring and setting standards to prevent problems which may arise during order processing, manufacturing and shipping. These processes shall be developed, scheduled, planned, and carried out under controlled conditions in a form suitable to the organizations method of operations. A quality plan specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract can be developed at this stage.

7	PRODUCT REALISATION
7.1	PLANNING

7. Product Realization

7.1 Planning of product realization

For all current range of products approved by the National Regulatory Authority established procedures and processes are in place ensuring that the product realization processes and the products conform to pharmacopeial, regulatory and customer requirements and expectations.

Planning of product realization for new products is consistent with current regulatory requirements, customer needs & expectations, company’s Quality Objectives and the requirements of the other processes of the Quality Management System.

The company also plans the product realization through, controls, approvals, monitoring and setting standards to prevent problems which may arise during order processing, manufacturing and shipping. These processes are developed, scheduled, planned, and carried out under controlled conditions in a form suitable to company’s method of operations.

The organization has determined the following:

     a.    Quality objectives and requirements for the product which is available in the form of quality specifications (for starting material, intermediates, drug substance, excipients, adjuvant, drug product, container closure system etc) meet or exceed the pharmocopeal/regulatory requirements. Other requirements such as delivery system, packaging, shipping, instruction for safe and effective use are defined and available.

     b.   All the processes of product realization specific to product are established through extensive scientific research and development and have been approved by the National Regulatory Authority. These processes are defined and performed under the controlled conditions.

The processes of manufacturing, testing, and control and support functions are performed as per Standard Operating Procedures (SOP), Standard Testing Procedures (STP), work instructions and protocols. No deviation is allowed from these procedures and documents. Evidence of each activity performed is captured in appropriate record forms.

Resources specific to the product are provided. Raw materials are purchased as per plan and tested for laid down specification. Once found acceptable the raw material is released for production. Personnel performing the manufacturing and testing activities are competent on the basis of appropriate education, training, skill and experience. Manufacturing facilities are compliant to the latest GMP requirements, suitable equipments are provided which are cleaned and maintained as per schedule, and instruments for process control and monitoring are calibrated and maintained, wherever applicable validated computer systems are provided. Environmental conditions applicable for product processing and personnel comfort are provided, controlled and maintained.

     c.    Entire process is controlled. Critical control points and critical process parameters are defined and controlled through suitable means (manual or electronic). Process at each step is verified, monitored, measured and tested against laid down specifications for proper process control. Processes which cannot be tested are validated at defined interval to maintain them in state of control. Raw material, starting material, intermediates, drug substance, excipients, adjuvant, drug product, container closure system etc are tested for defined specifications and released only if laid down criteria is met.

     d.         Records of manufacturing and testing processes are maintained in the form of activity record forms, manufacturing record forms, environmental records, data printouts, analytical reports, certificate of analysis etc., which are compiled in a batch document (consisting of Batch manufacturing record and batch analytical file). This data is reviewed along with the COA’s before batch is released for market.