QM: 7.2 Customer Related Processes (7.2.1, 7.2.2 & 7.2.3)

Customer-related processes

Introduction

ISO 9000 defines customer as an organization or person that receives a product or service and includes purchaser, consumer, client, end user, retailer, beneficiary and purchaser.

A customer can be internal or external to the organization.

Customers are stakeholders: they have entered into a commitment in return for some benefits that possession of a product or experience of a service may bring. Customers demand, request or otherwise place an organization under a commitment, implying that there is no such thing as an internal customer.

The customer is often thought of as the person who buys a product or service but, in the above definition, this is a customer who is a purchaser. The end user may not buy the product but is the person for whom the product or service is produced.

To understand the requirements of the clause it is important to identify the customers to the product.

The customer of the pharma/biopharma product are end user (consumer), regulatory agencies (for end user and for benefit of end user), stockiest, distributor, retailer, pharmacist, health care staff etc.

7.2	CUSTOMER RELATED PROCESSES
7.2.1	Determination of Requirements Related to Product
7.2.2	Review of Requirements Related to Product
7.2.3	Customer Communication

7.2 Customer-related processes

7.2.1  Determination of requirements related to product

The company’s prime focus is to reach out for the customers, understanding their environment and identifying solutions suitable to their needs and applications, which will both meet and exceed their expectations. The company focuses on innovations to provide quality product at competitive price thus providing health to all.

Requirements related to the product have been determined by the organization during the developmental stage and reviewed at regular interval for compliance with customer and regulatory requirements. Other requirements related to product which are determined, include:

• Requirements specified by customers (distribution companies, retailers, health care staff), including the requirements for products type and quantity and delivery time, transportation and storage control. All inquiries / tenders are carefully studied, before quoting, to identify that all requirements are adequately defined and there is no requirement which is beyond organization’s capability in terms of capability, specifications, delivery schedule etc. The orders are accepted only if the organization can meet the commitments and customer’s requirement. Any post delivery activity not identified during product realization are clarified and addressed before commitment to supply.

• Requirements not stated by the customer but necessary for intended use of the products such as requirements for unit pack configuration/packaging and instructions for safe use/administration, instruction for disposal. Such requirements once identified are clarified and agreed with before delivery.

• Statutory and regulatory requirements related to the product including the requirement stated in pharmacopeias or determined by National Regulatory Authority. These requirements are stated in manufacturing and testing plans.

• Organizational requirements and requirements stated by commercial partners. These requirements are clarified and incorporated prior to execution of the order and delivery of the products.

7.2.2 Review of Requirements Related to the Product

After the requirements related to product are determined and defined a formal review of all the requirements related to product is performed together with additional requirements that are not specified but are necessary for fitness for use and governed by laws and regulations, and requirements for availability, delivery, and support. The review is conducted to establish and maintain customer satisfaction before commitment to supply a product to the customer. The review ensures that: 

• Product requirements (including requirements related to delivery and post-delivery activities) are defined
• Special requirements of the product are determined
• Contract or order requirements differing from those previously expressed are resolved
• The organization has the resources, ability, capability and capacity to meet the requirements of the order / contract.
• Risks (e.g., short delivery time) have been identified

Records of the results of review and actions arising from this review are maintained.

When product requirements are changed, relevant documents are amended and the relevant personnel are made aware of the changed requirements. Documents for such changes are updated.

7.2.3 Customer Communication

Communications may address information related to product, inquiries, contracts, contract amendments, order handling, complaints, and advisory notices / recalls. Required arrangements for communication with customers relating to the followings are determined and implemented: 

·      Product information according to the customer communication procedure

·      Customers can contact the organization via phone, e-mail, fax and mail.

·      Enquiries, contracts or order handling, according to the sales procedure

·      Customer feedback, according to the customer communication procedure.

·      Enquiries, contracts and order handling, including amendments etc. are handled effectively.

      

Customer complaints are handled by Quality Department through the Sales Department. Customer feedback and complaints are classified into categories to allow for better tracking of trends and evaluating improvement in specific aspects (complaints follow-up procedure). Every complaint is communicated to relevant functions within and outside the organization. When appropriate, Quality Assurance may be requested to initiate corrective or preventive actions. When product recall is necessary, this process will be handled according to the product recall procedure.

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.