ISO 9001- Quality management system
ICH Q9- Quality risks management
GMP –Good manufacturing practices
ISO 14001- Environmental management system
ISO 31000 –Risks Management system
OHSAS 18001- Occupational health and safety management system
USFDA/MHRA/WHO GMP : Consultancy/Training/Audits
ISO 10002- Quality management- Customer Satisfaction- Guidelines for Complaints handling in organizations
Human Resources Business Risks Study
Human resources constitute the most significant accelerators for the growth of the organization. Human resources risks business study shall identify critical human resources and the risks associated from multiple perspectives how their departure or arrival of new such personnel could pose risks to the business goal of the organization. This study shall also highlight to what extent the existing selection and promotion systems are sound and efficient and overall employee satisfaction and other wise status and its impacts on business.
Quality Risks to Business
An organization has to continuously develop and maintain its customer base. Customers are driven by Quality and extent of complaints and defectives and robust quality assurance systems of the organization. Quality risks shall profile each products and its batches and various specifications parameters relating quality and other aspects of quality namely packaging, labelling, dispatches, storages etc which could have potential quality impacts on the products and services and thus impact the customer base. Quality risks prioritization shall be done and corrective and preventive actions recommended as part of the study.
Business Plan of the Organization
Business Plan reflects the dynamism of the organization. Business Plan must be absolutely clear and precise. It should not be at all clumsy and confusing and non affordable. The structure of the Business Plan need to formatted and finalized and methodologies finalized and the accuracy and authenticity of the data and growth rates projected. The organization has to ensure that Business Plan is prepared as per the approved procedure of the top management. Our consultancy shall lay down the architecture and structure and basis of Business Plan which when approved by the top management shall be as a basis and System for the making of the Business Plan Year wise subject to amendment with the approval of the top management.
Key Performance Goals of the Functional Heads.
Functional Heads are the Most Valued Resources of the Organization to ensure that the Achievements and Culture of the Organization is retained and improved. This consultancy shall focus on determining the optimal structure of key performance goals and parameters of each functional head in view of its relative importance to business and other compliances and improvements. A Comprehensive Structure of the key performance goals shall be formatted and finalized with the top management and this Structure then becomes the basis for assigning goals and also consider to award and determine remuneration/ incentives to the functional heads. This business study shall lay down an advanced comprehensive system of Key Performance Goals and procedure for MIS, authenticity of data and its review by the top management.
Implementation of ICH Q9 Quality Risk Management
An implementation of quality risks management involves identification of quality risks to active pharmaceutical ingredients and or pharmaceuticals right from research and development stage, manufacturing, storage, distribution till the pharmaceuticals reach the end point of the customers. This involves identification of quality risks and preventive actions on significant quality risks. This may involve one years time. The implementation shall involve training in risks identification methods namely DOE, FMEA, risks probability method, fault tree analysis etc.