Quality management system: Review on “Outsourcing”.
QUALITY MANAGEMENT SYSTEMS
Review on “Outsourcing”
Sunny Modi, Prof Manohar A Potdar
Poona College of Pharmacy, Bharati Vidyapeeth University, Pune, India
Keywords: Outsourcing, Contract, Contract giver, Contract acceptor, Responsibility.
Outsourcing is rapidly growing in the pharmaceutical industry. Most of the pharmaceutical industry outsource (contract) at least some activities or operations due to inadequate personnel, equipments, Analytical laboratories or due to any other reasons. In such cases regulatory authorities allow outsourcing or contracting services with the external party/supplier. Therefore outsourcing activity is more important and is carried out based on legal agreement between two parties i.e. organization (contract giver) and supplier (contract acceptor) and contains detailed and precise contractual specifications regarding data privacy and protection etc.
Outsourcing is the process of subcontracting to a supplier external to the organization an activity that is currently conducted in house.
Or
Outsourcing is the contracting of services or tasks to an external company.
Outsourcing fits well with the” just-in-time (JIT)” concept of minimizing waste in a company’s operations. Outsourcing is the company’s activities which should allow it to minimize the effects of fluctuating revenues in what has become a more dynamic business environment. Outsourcing therefore allows the company to maintain a basic level of operations in core departments but expand or contract out in areas in which additional resources are required. This can be done on a project by project basis. Outsourcing reduces internal costs, reduces cycle time or improves quality because the companies have adequate technology and knowledge to perform certain tasks more efficiently than some companies can internally. Outsource companies possess better developed skills in the particular area and a reduced cost structure in comparison to the client companies.
There are three primary considerations that need to be addressed when identifying the “right” supplier for the organization:
(1) Does the supplier have the proper training to assist with the validation programme?
(2) Does the supplier have adequate time to devote to the validation effort and are they willing to guarantee this contract?
(3) Has the supplier actually participated in this type of work previously? Have they actually done this specific work, and if so, are they willing to provide references?
Assuming these three primary considerations are met, a fourth and extremely critical factor to consider is whether the supplier has the type of personality that will allow for effective integration into the project team. The supplier must be integrated into the overall cooperative partnership that is necessary for successful validation. The organization must certain that the supplier has the necessary interpersonal skills to build and maintain the proper relationship for a long time.
The contract giver must work closely with the supplier to ensure all the regulatory “bases” are covered.
Reasons for Outsourcing
Organizations that outsource are seeking to realize benefits or address the following issues:
· Cost Savings. The lowering of the overall cost of the service to the business. This will involve reducing the scope, defining quality levels, re-pricing, re-negotiation, cost re-structuring. Access to lower cost economies through off shoring called “labor arbitrage” generated by the wage gap between industrialized and developing nations.
· Cost Restructuring. Operating leverage is a measure that compares fixed costs to variable costs outsourcing changes the balance of this ratio by offering a move from variable to fixed cost and also by making variable costs more predictable.
· Improve Quality. Achieve a step change in quality through contracting out the service with a new Service Level Agreement.
· Knowledge. Access to intellectual property and wider experience and knowledge.
· Contract. Services will be provided to a legally binding contract with financial penalties and legal redress. This is not the case with internal services.
· Operational Expertise. Access to operational best practice that would be to difficult or time consuming to develop in-house.
· Staffing Issues. Access to a larger talent pool and a sustainable source of skills.
· Capacity Management. An improved method of capacity management of services and technology where the risk in providing the excess capacity is borne by the supplier.
· Catalyst for Change. An organization can use an outsourcing agreement as a catalyst for major step change that can not be achieved alone. The outsourcer becomes a Change Agent in the process.
· Reduce Time to Market. The acceleration of the development or production of a product through the additional capability brought by the supplier.
· Co modification. The trend of standardizing business processes, IT Services and application services enabling businesses to intelligently buy at the right price. Allows a wide range of businesses access to services previously only available to large corporations.
· Risk Management. An approach to risk management for some types of risks is to partner with an outsourcer who is better able to provide the mitigation.
· Time Zone. A sequential task can be done during normal day shift in different time zones – to make it seamlessly available 24×7. Same/similar can be done on a longer term between earth’s hemispheres of summer/winter.
Activities Mainly Outsourced:
The list below shows the types of activities currently outsourced by many organizations are,
· Manufacturing/Packaging of finished products
· Validation services
· Calibration activities
· Analytical testing/Analytical method development etc.
· Auditing services
· Other services i.e. security, pest control etc.
General guidelines for outsourcing: Based on USFDA guidelines outsourcing operations can be divided into three parts in terms of individual responsibilities.
(1) Contract Giver:
· The contract giver is responsible for assessing the competence of the contract acceptor in successfully carrying out the work or tests required and for ensuring by means of the contract that the principles of GMP are followed.
· A contract giver should assure him self that the contract acceptor has adequate premises, equipment, and staff with sufficient knowledge and experience, to carry out satisfactorily the work given to him. For this purpose the contract giver should carry out technical audit of the contract acceptor. This audit is required to be carried out before the activities are stared and at regular intervals thereafter. Audit reports should be issued and kept on record.
· A contract giver may only use the contract manufacturer, packer or analytical services as approved in the registration dossier.
· A contract giver shall not authorise a contract acceptor to commence manufacturing, packing, testing of a medicine, until he has assured himself, and authorised by him, that all necessary master documents and/or specifications, generated by contract acceptor for use in his own facility, are in accordance with the particulars contained in contract giver, master documentations and registration dossier.
· The contract giver should provide the contract acceptor with all the information necessary to carry out the contracted operations correctly in accordance with the marketing authorisation and any other legal requirement.
· The contract giver should ensure that the contract acceptor has fully aware of any problems associated with the product, work, or tests that might pose a hazard to premises, equipment, personnel, other materials or other product.
· The contract giver should ensure that all provided products and materials delivered by contract acceptor comply with their specifications or that the product has been released by the authorised person(s).
(2) Contract Acceptor:
· The contract acceptor must have adequate premises, equipments, knowledge and experience and competence personnel to carry out satisfactorily the work ordered by the contract giver. Contract manufacturer can only be undertaken by manufacturer who holds a manufacturing authorisation.
· The contract acceptor should not pass to third party any of the work entrusted to him under the contract without the contract acceptor givers prior evaluation and approval of the arrangements. Arrangements made between the contract acceptor and any third party should ensure that the manufacturing and analytical information is made available in the same way as between the original contract giver and contract acceptor.
· The contract acceptor should refrain from any activity that may adversely affect the quality of the product manufactured and/or analysed by contract giver.
· The contract acceptor should ensure that all products or materials delivered to him are suitable to their intended use.
· If a contract acceptor supplies materials, the contract giver should specify the quality required in the specifications/master document.
(3) Contract:
· The contract should be drawn up between the contract giver and the contract acceptor specifies their respective responsibilities relating to the manufacture and control of the product. Technical aspects of the contract should be drawn up by competent persons suitably knowledgeable in pharmaceutical technology, analysis and GMP. All arrangements for production and analysis must be in accordance with the marketing authorisation and agreed by both parties.
· The contract should specify the way in which authorised person releasing the batch for sale ensures that each batch has been manufactured in, and checked for compliance with the requirements of the marketing authorisation.
· The contract should describe clearly who is responsible for purchasing, testing and releasing materials and for undertaking production and quality control, including in process controls and who has responsibility for sampling and analysis. In case of contract analysis the contract should state whether or not the contract acceptor should take samples at the premises of the manufacturer.
· Manufacturing, analytical or any other records and reference samples should be kept or be available to, contract giver. Any records relevant to assessing the quality of a product in the event of complaints or suspected defect must be accessible and specified in the defect/recall procedure of the contract giver.
· The contract should describe the handling of the starting materials, intermediates, bulk products or finished products, if they are rejected. It should also describe the processing of information if the contract analysis shows that the tested product must be rejected.
Contract finalization
At the heart of every outsourcing deal is a contractual agreement that defines how the sponsor and the supplier will work together. This is a legally binding document and is core to the governance of the relationship. There are three significant dates that each party signs up to the contract signature date, the effective date when the contract terms become active and a service commencement date when the supplier will take over the services.
Conclusions:
This article gives the idea of the outsourcing operations and benefits of the outsourcing services based on FDA audit questionnaire or any other regulatory requirements and selection of the supplier. Outsourcing is the new pathways for the organization to carry out his business by means of more efficient, effective, and cost-competitiveness based on rising customer expectations, dwindling pipeline for the new blockbusters, ever-increasing regulatory burden, reducing the cycle times, and minimizing the time to market. So, the need for contracting with an outside supplier has become necessary business strategy for the pharmaceutical industry. After the initial evaluation of the supplier, the successful contract validation will enable both parties to achieve the economic benefits desired.
References:
(1) Draft Guidance for industry, “Quality system approach to pharmaceutical current good manufacturing practice regulation”, September 2004, pharmaceutical CGMPs.
(2) U.S.Food and Drug Administration Centre for Drug Evaluation and Research, “21 Code of Federal Regulations Parts 210 and 211”.
(3) Validation of Pharmaceutical Processes, Third Edition, by James Agalloco and rederick J. Carleton.
(4) Validation in Contract Manufacturing by Dilip M. Parikh, Maryland, U.S.A.
(5) Anu Linna, Mirka Korhonen, et. al., “Developing a tool for the preparation of GMP audit of pharmaceutical contract manufacturer”.
(6) D. Smith, The effect of outsourcing on the pharmaceutical – fine chemical industry relationship, Pharm. Technol. 24 (Suppl. 8) (2000) 52–56.
(7) Juan’s Quality Planning & Analysis for Enterprise Quality, Fifth Edition by Joseph M.Juran, Tata McGraw Hill.
(8) A.D. Bardhan and C. Kroll, The New Wave of Outsourcing (2003).
(9) Mark Kobayashi-Hillary. 2004. (2nd ed 2005) Outsourcing to India. ISBN 3-540-23943-X.
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Design and Develop Product and Processes
Quality Management System
Design and Develop Product and Processes
Prof. Manohar A. Potdar
Head of Quality Assurance Department, Poona College of Pharmacy, Pune, India
Mr. Prafulla P. Apshingekar
Quality Assurance Department, Poona College of Pharmacy, Pune, India
Product development is the process of creating a new product to be sold by a business or enterprise to its customers. In the document title, Design refers to those activities involved in creating the styling, look and feel of the product, deciding on the product’s mechanical architecture, selecting materials and processes, and engineering the various components necessary to make the product work. Development refers collectively to the entire process of identifying a market opportunity, creating a product to appeal to the identified market, and finally, testing, modifying and refining the product until it is ready for production.
The task of developing outstanding new products is difficult, time-consuming, and costly. People who have never been involved in a development effort are astounded by the amount of time and money that goes into a new product. Great products are not simply designed, but instead they evolve over time through countless hours of research, analysis, design studies, engineering and prototyping efforts, and finally, testing, modifying, and re-testing until the design has been perfected.
As a general rule, the cost of a development effort is a factor of the number of people involved and the time required to nurture the initial concept into a fully-refined product.
(a)“ In modern quality systems manufacturing environment, the significant characteristics of the product being manufactured should be defined, from design to delivery and control should be exercised over all changes.”
A pharmaceutical Product should be designed in such a way that it should meet five basic characteristics namely, identity, strength, safety, purity & efficacy. By keeping this in mind, specifications for required product are finalised.
Change control is another well-known CGMP concept that focuses on managing change to prevent unintended consequences. The CGMP regulations provide for change control primarily through the assigned responsibilities of the quality control unit. Certain major manufacturing changes (e.g., changes that alter specifications, a critical product attribute or bioavailability) require regulatory filings and prior regulatory approval.
Effective change control activities (e.g., quality planning and control of revisions to specifications, process parameters, procedures) are key components of any quality system. In this guidance, change is discussed in terms of creating a regulatory environment that encourages change towards continual improvement. This means a manufacturer is empowered to make changes subject to the regulations based on the variability of materials used in manufacturing and process improvements resulting from knowledge gained during a product’s lifecycle.
(b) “Quality and manufacturing processes and procedures and changes made to them should be defined, approved, and controlled. Responsibility of person in this regard should be established.”
It is important to establish responsibility for designing or changing product. Documenting associated processes will ensure that critical variables are identified.
There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in this subpart. These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit. Written production and process control procedures shall be followed in the execution of the various production and process control functions and shall be documented at the time of performance. Any deviation from the written procedures shall be recorded and justified.
Both (a) and (b) should be documented, this documentation must include -:
Þ Resources and facilities needed
Þ Procedures to carryout the process
Þ Identification of the process owner who will and update the process
Þ as needed
Þ Identification and control of critical variables
Þ Quality control measures, necessary data collection, monitoring, and
Þ appropriate controls for the product and process
Þ Any validation activities, including operating ranges and acceptance
Þ criteria
Þ Effects on related process, functions, personnel
(c) “Management should see that product specifications and process parameters are determined by technical experts. e.g. engineers, microbiologist, chemist, pharmacist, etc..”
Few products are developed by a single individual working alone. It is unlikely that one individual will have the necessary skills in marketing, industrial design, mechanical and electronic engineering, manufacturing processes and materials, tool-making, packaging design, graphic art, and project management, just to name the primary areas of expertise. Development is normally done by a project team, and the team leader draws on talent in a variety of disciplines, often from both outside and inside the company.
In the pharmaceutical environment, experts must have an understanding of pharmaceutical science , risk factors, and manufacturing process as well as how variations in materials and process can ultimately affect the finished product.
The process of developing new products varies between companies, and even between products within the same company. Regardless of organizational differences, a good new product is the result a methodical development effort with well defined product specifications and project goals.
REFERENCES
1. Guidance for Industry -Quality Systems Approach to Pharmaceutical CGMP Regulation(http://www.fda.gov/CDER/guidance/7260fnl.htm)
2. 21 code of Federal Regulation (21 CFR 314.70, 514.8, and 601.12).
3. Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals–21 CFR Parts 21 CFR part 21.100(a)
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Structure the Organization As Management Responsibility In Quality Management System
Quality Management System
Prof. Manohar A. Potdar
Head of Quality Assurance Department, Poona College of Pharmacy, Pune, India
potdar_manohar@yahoo.com.au
Vibhu Nagpal
Quality Assurance Department, Poona College of Pharmacy, Pune, India
Management Responsibilities
Structure the organization is one of the main point given by Comprehensive quality management system for explaining management responsibilities in a pharmaceutical organization.
“Structure the Organization”
Organizations are groups of people, with ideas and resources, working toward common goals. The purpose of the organizing function is to make the best use of the organization’s resources to achieve organizational goals. Organizational structure is the formal decision-making framework by which job tasks are divided, grouped, and coordinated. Formalization is an important aspect of structure. It is the extent to which the units of the organization are explicitly defined and its policies, procedures, and goals are clearly stated. It is the official organizational structure conceived and built by top management. The formal organization can be seen and represented in chart form. An organization chart displays the organizational structure and shows job titles, lines of authority, and relationships between departments.
Steps in Organizing Process
1. Review Plans
2. List Tasks
3. Group Tasks into Jobs
4. Group Jobs
5. Assign Work
6. Delegate Authority
“Management should determine the structure of the organization and document the same”.
In designing and implementing a Quality system, an organization determines the regulatory requirements for their work procedures and products and adopts quality system requirements from voluntary standards such as ISO 9001.
Implementing a Quality Management System (QMS) within an organisation needs a decision by top management. The objective of the quality system needs to be clearly defined so that the system can be effective.
The design and implementation of a quality management system will vary depending on the type, size and products of the organisation. Each company will have its own objective, however most companies’ objective is to increase profitability. A Quality Management System will assist by:
·managing costs and risks
·increasing effectiveness and productivity
·identifying improvement opportunities
·increasing customer satisfaction
Management commitment is essential for the implementation and ongoing success of the Quality Management System. QMS objectives must be measurable and reflect the overall company objectives. For managing QMS adequate resources must be allocated. The system must be reviewed regularly and measured for effectiveness; adjustments must be made to reflect major changes to the organisation and business practices.
The system must be practical and accessible to all concerned employees within the organisation.
“Management should communicate employee roles, responsibilities and authorities with in the organization”.
Management responsibilities:
In implementing a quality system, the first responsibility of an organization’s management is to demonstrate their support. Management leadership and participation is necessary for a quality system to be effectively implemented and sustained.
a) Senior managers are committed to the development, implementation, maintenance, and improvement of a quality system that meets customer needs as well as regulatory/ statutory requirements. They make their commitment evident by
1. establishing and documenting the quality policy, strategic plans, work objective and quality objectives.
2. participating in QMS management review and in follow up actions. And
3. ensuring the availability of resources for conducting work and QMS processes.
b) Managers demonstrate their commitment by
1. establishing quality plans for work activities.
2. communicating the importance of a customer orientation when fulfilling quality requirements.
3. participating in review of their unit’s quality system and in follow up actions.
4. assuring communication, understanding and implementation throughout unit.
Responsibility and Processes Involved
1. Management
Process I
Þ Set objectives and goals of the QMS
Þ Appoint a quality team to develop and maintain QMS
Þ Set timelines and project scope
Þ Allocate resources required for the development, implementation and on going management of the system
Þ Inform all staff and seek participation from all levels
2. Management/ Quality Team
Process II
Þ Decide if a Consultant is required for the project
Þ Prepare a project plan and allocate resources
Þ Assess an appropriate budget based on equipment, training, time and personnel required
Þ Seek approval from management to procure required resources and attend any training
3. Quality Team
Process III
Þ Assess method for documenting the QMS
Þ Design templates and documentation
Þ Set timelines for the various tasks
Þ Schedule individual departments and positions for development of policies and Procedures
4. Quality Team/ management
Process IV
Þ Develop QMS policies to reflect company objectives
Þ Start to develop procedures and work instructions with each department
Þ Report to management any risks improvement opportunities that have been found
Þ Document any Quality corrective action requests that might be identified (identified risk areas that require management attention and improvements)\
5. Management
Process V
Þ Approve and issue the QMS
Þ Operate the QMS for a minimum period of 3 months
6. Quality Team
Process VI
Þ Carry out initial audits to ensure documentation matched processes
Þ Ensure that “ you do what you say you do” if any deficiencies are found either change processes or change the QMS and implement any changes that might be required
7. Management
Process VII
Þ Undertake management review of the QMS
Þ Adjust resource requirements
Þ Decide if accreditation assessment is required
Þ Set accreditation assessment timelines
Þ Appoint Accreditation Body
8. Accreditation Body/ International drug regulatory auditors. E.g. USFDA, MHRA. Etc
Process VIII
Þ Audit
Þ Report findings to management including any changes required to the QMS
9. Quality Team/ Management
Process IX
Þ Make changes to the QMS according to the findings of the Accreditation Body
Þ Advise Accreditation Body to reassess the QMS
10. Accreditation Body/ International drug regulatory auditors. E.g. USFDA, MHRA. Etc
Process X
Þ Undertake follow-up Audit
Þ If all requirements are met, accreditation will be issued.
11. Quality Team/ Management/ Accreditation Body
Process XI
Þ Continue to audit, review and Assess the QMS at the agreed time intervals
Þ Continue to assess risk areas and identify improvement opportunities
Þ Continue to review policies and procedures and make amendments as required
Þ Continue to measure effectiveness of QMS to the overall company performance
“Management should give authority to employees for detect problems and effect solutions”.
There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labelling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. The quality control unit shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company.
Quality control unit (Q.C.) means any person or organizational element designated by the firm to be responsible for the duties relating to quality control.
Q.C = Q.A. + Q.C. laboratories.
The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product.
The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed.
Procedures shall be established to assure that the responsible officials of the firm, if they are not personally involved in or immediately aware of such actions, are notified in writing of any investigations conducted under complaint files, return good products and drug product salvaging of these regulations, any recalls, reports of inspectional observations issued by the Food and Drug Administration, or any regulatory actions relating to good manufacturing practices brought by the Food and Drug Administration.
Conclusion
Organization use directives and evidentiary records to establish and maintain a quality system and to support effective and efficient work processes. Work quality depends on access to accurate and timely direction, requiring organizational control of directives, i.e. defined approved and availability of the proper revision in it’s entirely. An organizations record provides evidence of conformance to process and product requirements and of the effective management of the quality system. Records need to be accurate, complete and controlled.
References:
1. Draft Guidance for Industry Quality System Approach to Pharmaceutical Current Good Manufacturing Practice Regulations, September 2004.
2. 21 Codes of Federal Regulations Parts 210 and 211.
3. ORA (Official Regulatory Affairs) Quality Manual January 2007 Department of Health and Human Services Food and Drug Administration Office of Regulatory Affairs Quality Management System.
4. Organizing process, Management modern BMGT-1301 DCCCD Supervision, Gemmy Allen, 1998.
5. Quality Standards ISO 9001:2000 Quality Management System.
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Current Good Manufacturing Practices 