Auditing Service
ASA-SANTHILL is regularly involved in auditing related to GMP and GLP. We can conduct GLP inspections and carry out technical/documentation reviews with respect to GMP issues.
ASA-SANTHILL contributes to the GMP auditing process of clients’ facilities by reviewing documentation to ensure that product-specific issues are addressed. Our expertise has also been called upon during GMP inspections, either to aid in the inspection process or to liaise with the inspecting authorities.
Safety
ASA-SANTHILL conducts training in manufacturing risk assessment and management with a view to meeting the increasing industrial safety.
Quality Assurance
Quality assurance QA)is the totality of the arrangements made in a manufacturing facility with the aim of ensuring that products are of the quality required for their intended use. It includes the systematic measurement, comparison with a standard, monitoring of processes and an associated feedback loop that confers error prevention. ASA-SANTHILL can assist the client to assure the quality of their products. We can render the following services:
– DEVELOPMENT OF ASSAY PROCEDURES
– MICROBIOLOGICAL EVALUATION
– cGMP AUDITS
– ADVICE ON THE SETTING UP OF FOOD, COSMETICS AND PHARMACEUTICAL FACILITIES
– DEVELOPMENT OF PREVENTIVE AND CORRECTIVE MAINTENANCE PROCEDURES
– DEVELOPMENT OF VALIDATION PROCEDURES FOR PRODUCTION PERSONNEL AND EQUIPMENT
– PREPARATION OF STANDARD OPERATING PROCEDURES (SOPs) FOR PRODUCTION, MAINTENANCE, CLEANING AND QUALITY CONTROL
– ANALYTICAL AND PHYSICAL TESTING OF RAW AND PACKAGING MATERIALS AS WELL AS FINISHED PRODUCTS.