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
GMP Audits for Checking Level of Compliance Against WHO GMP, USFDA MHRA Etc.
A 05 Days Audit can be conducted for an active pharmaceutical ingredients or pharmaceutical formulations manufacturing unit against the selected GMP requirements and audit gaps relating infrastructure, need for modifications, specifications, batch manufacturing records, OOS, market returns, validations, qualifications, housekeeping, document control, change control etc. can be highlighted to bring the organization at the level of the compliance. GMP audits shall be done from research and development to delivery processes. Each clause of the selected system shall be comprehensively audited through audit checklists including the level of knowledge with the employees and functional heads.
Audits of the Suppliers Quality Assurance System
The Quality of the products and services of an organization depends on the quality capability and quality assurance system of its inputs and services providers. We can plan and conduct independently or as part of your purchase and quality teams the quality capability of suppliers of products and services. Auditing shall focus on technical, technological, storage, sampling/ quality control, quality assurance, potential quality risks, potential EHS risks and other aspects based on risks ranking system assigned for each parameter demonstrated by the supplier. The auditing schedule could be from 2-5 days depending on the size and complexity of organization and number of products and services supplied by the supplier. The audit shall result recommendation to the organization and suppliers on a clear concise plan of corrective and preventive actions for ensuring sustained business to the organization and its outsourced processes.
Legal Compliance Audits and Risks to Business
For an organization, there are number of Acts/Regulations/Rules are applicable. On an average, each organization has to comply not less than 20 rules and regulations relating various aspects of its operations including quality, manufacturing, environment, health and safety and other aspects. As per the terms agreed with the organization, the legal compliance audits can be planned and conducted with a focus on risks values assigned to each kind of non compliances and actions plans for permanent changes in the procedures and systems for controlling and reducing the identified risks during legal compliance audits.