Qualisure helps the organizations to establish, implement, and maintain robust quality management systems (QMS) in line with GMP guidelines. This includes creating standard operating procedures (SOPs), quality manuals, and documentation systems.
Also, set up procedure for customer complaint handling, deviation management, change Control management, out-of-specification, non-conformance procedures, Product Specification, corrective action, and preventive measures.
Our expert performs internal audits, contract manufacturing site audits, supplier site Pre- approval audits to identify potential compliance issues and prepare organizations for regulatory inspections. They also offer guidance on addressing any deficiencies found during inspections.
Qualisure provides GXP training programs for employees at all levels to ensure they understand and adhere to GMP guidelines. This includes training in areas such as Good Sanitization Practices, Good Manufacturing Practices, Good documentation Practices, Good Warehouse Practices and Good Laboratories Practices.
Qualisure helps companies establish and maintain the required documentation and record-keeping systems to track every aspect of the manufacturing process, from receiving raw materials to dispatch of finished products.
Qualisure helps organizations implement measures to protect against intentional adulteration and food fraud, as well as ensuring the authenticity of food products.
Qualisure helps develop and implement food safety programs based on Hazard Analysis and Critical Control Points (HACCP) principles. This includes identifying potential hazards, establishing control measures, and monitoring processes to ensure food safety.
Qualisure helps in implementing and overseeing a Supplier Management program to ensure the quality of incoming materials
Qualisure helps in developing and implementing an allergen management program to address potential allergen-related issues.
Qualisure design facility health &hygiene program for facility cleanliness and hygiene.
We help to develop recall plans and procedures to address situations where product recalls become necessary due to safety concerns.
Qualisure works with organizations to implement quality risk management strategies, which involve identifying, assessing, controlling, and communicating potential risks to product quality.
Qualisure helps in designing manufacturing and storage facilities with GMP in mind. This includes proper ventilation, cleanliness, and sanitation procedures.
Our team provides support in the validation of manufacturing processes, ensuring that they are consistent and produce high-quality products. This may involve drafting validation master plans, process qualification, and ongoing monitoring.
Our team performs risk assessments to help organizations to identify and assess potential risks in their manufacturing processes and supply chains and provide remedies to mitigate these risks and ensure product quality and safety.
Qualisure ensures that product labeling accurately represents the contents, and that it complies with regulatory requirements.
© 2024 Qualisure Consulting Services. All Rights Reserved | Design by Iseven Technologies