SperaMed provides range of QA audit services that covers GCP, GVP, GMP, CSV including vendors and infrastructure audits. We have global reach and have experience in conducting GxPaudits across India, China, South Korea, Taiwan, Australia, Asia Pacific, Europe and North America.

Clinical Trials (GCP):

  • Clinical Investigator Site audits (for-cause and routine)
  • Study/Trial Master File audits
  • Study document (Protocol, Informed Consent, Clinical Study Reports) audits
  • Clinical Database set-up/lock audits
  • Vendor audits (including central/bioanalytical laboratories (GcLP), Drug depots, BA/BE &Phase I Units, CROs (full services and targeted service providers), Translators, Archiving facilities, Ethics Committees, EDC/IWRS/IVRS facilities)
  • For cause audits including root cause analysis and corrective and preventive action (CAPA) program
  • Process/System audits, GAPanalysis and process improvement exercise for Data Management, Pharmacovigilance, Sponsor, CROs
  • Management of audit programs

Pharmaceutical Manufacturing (GMP)

  • Good Manufacturing Practices audits and reviews
  • Quality Management System implementation and gap analysis
  • Quality audits of manufacturers, suppliers, distributors, and contractors of both sterile and non-sterile, APIs and Finished Drug Products
  • Process, analytical and equipment validation audit and support
  • Quality Assurance and Quality Control operational support
  • Regulatory inspection readiness support
  • Documentation design, generation, and maintenance support
  • Quality risk assessment and mitigation support
  • Training of staff in areas of pharmaceutical manufacturing and regulatory compliance
  • QA audit of clinical trial supplies manufacturing and packaging facilities

Pharmacovigilance (GVP)

  • Pharmacovigilance system audits
  • Pharmacovigilance process and record management audits
  • Inspection and audit readiness
  • Risk-based audit
  • Reporting & remediation support

Vendor/Supplier & Infrastructure Audits

  • Central Laboratory
  • Data Management, Biostatistics & Medical Writing
  • Electronics applications like EDC, IVRS/IWRS, ECG, Imaging, ePRO, DCTetc. service providers
  • Archival facilities
  • Clinical Lockers (Clinical Trial Supplies)
  • Translating agencies
  • IRBs / IECs
  • Contract Research Organisations and Site Management Organisations

Computer System Validation

  • Computer System Validation services across GxP (GCP, GMP, GLP)
  • System, Software, Equipment and Process Validation
  • Data integrity solutions: Policy & Process review, Gap assessments & Remediation
  • Compliance assessment with respect to various regulatory requirements and global standards e.g. CFR Part 11, GAMP5, Annex 11 etc.
  • SOP development, review & management: Due diligence, enhance, lean documentation
  • Development of Validation SOPs, Validation Plan & Documentation package

Bioavailability, Pharmacokinetic, Bio-equivalence & Phase I services

We provide independent auditing services for both the clinical and bio-analytical phases of the bioequivalence (BE), bioavailability (BA) and Phase I studies through our highly qualified and experienced consultants for BA/BE/Phase I work. Our services on BA/BE/Phase I studies include:

  • BA/BE/Phase I site audits (preaudit qualification, in-process audit and retrospective audits)
  • BA/BE/Phase I independent monitoring& oversight (in-process and retrospective)
  • Bio-analytical monitoring/audit (in-process and retrospective)

Medical Device

Several Quality System regulations applies to the manufacturing of medical device, and it is required to establish and maintain compliant quality management systems toensure they meet the required regulatory quality standards. SperaMed offers broad range of audit and consulting services which includes:

  • Gap Assessment to determine your current level of compliance to relevant quality requirements including GMP, ISO 13485, 21CFR Part 820, ISO 14971, MDSAP, QMS etc.
  • Qualification and Validation – Manufacturing processes, equipment, facilities, andcomputer systems associated with medical device.
  • Pre-assessment audits– are conducted at the end of implementation program to identify any gaps in the system before certification audit.