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
Implementation of Quality Management System
Implementation of Quality Management Systems based on ISO 9001-2008 to focus and ensure that requirements of the organization, customers and regulatory are designed,documented, training provided and implemented and systems remain effective and ensure continual improvement.
Implementation of environmental management system
Implementation of environmental management system is a strategic decision of the organization for promotion of environment, prevention of pollution and control and reduction of environmental risks relating its operations and as expected under regulatory compliance. An implementation involves design, documentation and implementation and training of the environmental management systems followed by environmental management system audits. Significant environmental risks need to controlled through programmes and other methods. An effective implementation of environmental management system is beneficial for all stakeholders.
An Implementation of EHS Management System
An Implementation of Environment, health and safety management systems based on ISO 14001 and OHSAS 18001 as an integrated system offers strategic advantages to the organization namely promotion of EHS goals/objectives, legal compliance and continual improvement in the environment, health and safety. The organization controls and prevents its significant EHS risks and demonstrates saving of water, energy and other resources including the waste.
An Implementation of Risks Management Systems based on ISO 31000
Each organization faces various kinds of risks in the organization it works and operates. An implementation of risks management system is a comprehensive process. When integrated with general management systems of the organization, risks management system ensure identification of significant risks to the organization and their preventive actions through systematic planning, training and changes in the management systems.
Master Validation Plan
Documentation, review and approval and implementation of Master Validation Plan is a must for all APIs/ Pharmaceuticals units. Master Validation Plan spells out all aspects of Validation in all kinds of permutations and combinations. It sets the parameters for equipment specifications; process flows; equipment qualifications; cleaning and process validations; introduction of new or modified products, equipments, software, hardware, processes, regulatory requirements. It is a comprehensive document for quality assurance and regulatory compliance. We shall design and document all aspects of Master Validation as a long term sustainable document for Quality Assurance.
Modification in the API Plant and Premises- API and Pharmaceuticals
To meet the needs of the customers, Active Pharmaceuticals Manufacturers and Pharmaceutical formulation manufacturers need to assess their premises, plant and equipments with respect to regulatory requirements and needs of the customers. We can carry out a comprehensive study of the API plant / formulation plant and suggest what are the key gaps with respect to the Equipments/ Systems, utilities, flooring, air handling units, heating ventilation and air conditioning, storage of materials in general and controlled conditions, the quality of packaging materials, resources namely microbiology laboratory, stability room and process flow of raw materials, packaging materials, processed materials, finished products, rejected materials; movement of personnel and movement of various kinds of wastes. Report shall highlight with respect to agreed GMP guideline the areas for improvement/ modifications for required change controls.
Implementation of ICH Q7
ICH Q7 is a guidance document for Good Manufacturing Practices for Active Pharmaceutical Ingredients. Consultancy shall involve design, documentation, training, implementation, validation and audits of the installed, modified and improved GMP systems to ensure that all requirements as listed in ICH Q7 are implemented effectively. This may take one to two year periods for effective implementation.
High Quality GMP Documented Systems
High Quality GMP documents compliant with regulatory requirements can be installed in your organization. Once the documents based on cGMP are established the organization can quickly ready itself for meeting regulatory audits requirements and customer requirements.
HACCP : An Implementation
For all ingredients of foods/processed industry; an effective implementation of HACCP is a critical and essential requirement. We can design, document and implement an effective management systems based on HACCP and current Good Manufacturing Practices whether you are supplying food based raw materials or processing food materials for end customers. The project involves identification of critical risks during product realization process and addressing of such critical quality risks through preventive mechanisms.
An Implementation of ISO 15378 for pharmaceutical packaging materials
ISO 15378 addresses the requirements of an implementation of Quality requirements for primary packaging materials for pharmaceutical applications. ISO 15378 is a sum of good manufacturing requirements and quality management system.