Compliance with industry regulations is not just a requirement…….. It’s Good Business.
More than 80% of the audits that SPRASH performs are conducted for “Repeat Customers”.
1. Mock Regulatory Audits/ Pre-approval GMP Inspection /Inspection Readiness
We assist our clients to prepare for an imminent regulatory inspection by carrying out one or more mock regulatory audits in advance. Our consultants will visit your facility and carry out an inspection in the style of the relevant Regulatory Body (Local FDA, USFDA, MHRA, EMEA) after which we provide:
* Evaluate preparedness of manufacturing facilities for regulatory inspections.
* Assess readiness of site personnel for pre-approval inspections by FDA/Regulatory agencies.
* In-depth, impartial & professional assessment of current state of compliance.
* Detailed, prioritized action plan for rectification of areas of non-compliance and vulnerability .
* Prepare personnel for inspector interviews .
* Compare Chemistry Manufacturing & Controls (CMC) submissions against supportive Documentation.
* Assess technical transfer for Manufacturing and Test Methods.
* Review submitted method validations.
2. GMP GAP Analysis Audits
SPRASH PHARMA CONSULTANCY will visit your site and perform an audit to determine scope of improvement with processes, documentation, and operations. We have experienced team who are able to perform GMP Audit Readiness/GMP GAP assessments for your facility against GMP requirements as well as offer assistance in correcting any deficiencies found.
3. Third Party Audits
SPRASH can assist you in your search for the “ideal contractor” by performing audits on your behalf for:
* Production * Packing * Testing * Storage and distribution * Range of vendors & suppliers * Water System * Raw material suppliers * Engineering SRASH will provide you with a detailed, balanced report highlighting:
* Company’s strengths and vulnerabilities .
* Recommendations for short, medium & long term remedial actions .
*Overall recommendations as to the suitability of the contractor for your needs
4. Second Party Audits (Vendor GMP Audits)
* Perform Routine & Qualification audits of Contract facilities used for Manufacturing, Packaging, and Labeling and Distribution.
* Perform Routine & Qualification audits of Contract Labs and Suppliers of drug substance (APIs), raw materials (Excipients), and Packaging components.
* Inspect Facilities and Equipments.
* Assess Qualification and Training of personnel.
* Review Organisation Structure SOP content.
* Assess Quality Systems.
5.GMP Clinical Trial Materials
* Review labeling for compliance to clinical protocols
and the regulations * Evaluate suppliers of raw materials, packaging, and labeling components, and distribution of clinical trials materials.
6. Facility Audits
* Inspect facilities, equipments, and laboratories.
* Review all permit documents that support GMP and client specifications.
* Assess Quality system, including all internal SOPs & associated CGMP documents.
* Assess CAPA programs.
* Review validation of manufacturing equipment, product process, & equipment cleaning.
* Assess Vendor Certification Programs.
* Review Method Validation (analytical and microbiological).
* Evaluate data integrity.
7. GMP Quality Systems.
* Assess Quality Systems Components, such as internal SOPs, specifications, change control, trend analysis, input inspection, outsourced operations control, and personnel development
* Assess CAPA Programs.
8 GMP Validation * Review method validations (analytical and microbiological).
* Review validation of manufacturing equipment, product process, and equipment cleaning.
9. Data and Document Auditing Clear and consistent documents contribute to a faster approval time. Our data and document quality assurance team at SPRASH is extremely detailed-oriented.
We can conduct quality audits on your data, reports, and documents, and make sure they are both compliant with applicable regulations and internally consistent.