Transfer and registration

We are experts in pharmaceutical industry standards,
and we will support your quality and registration activities hands-on

Support of GMP activities

  • Identification of CQAs and CPPs and their ranges (ICH Q8)

  • Equipment qualification (FAT, SAT, IQ, OQ, PQ)

  • Process flow diagrams

  • Contamination Control Strategy (Annex I)

  • Risk analysis, FMEA

  • Gap analysis for process and method transfers

  • QA documentation

  • Tech transfer project management

Support of API and drug product registrations

  • Registration strategy

  • Analytical method development, optimisation and validation

  • ASMF and registration dossier gap analysis

  • ASMF and registration dossier compilation

  • Support of the registration process

  • Help with preparation of answers to deficiency letters (including experimental support)

  • Project management

Support of computer and automated systems under GMP according to FDA, EMEA, and MHRA requirements

  • Computerised system validation

  • Validation of automated and electronic devices  (commissioning, design qualification)

  • Assessment of computerised systems compliance with 21 CFR Part 11

  • Data integrity (ALCOA, ALCOA+) within cGMP and GLP environment

  • QSR (Quality System Regulation) evaluation with focus on computerised system validation, software (VMP, testing, change management, incident management, etc.)

  • IT infrastructure qualification

  • Validation/qualification in the XaaS environment

  • Vendor assessment with focus on CSV and IT infrastructure

 

Trainings:

  • Computer system and spreadsheet validations (MS Excel)

  • Data integrity

  • Validation of equipment containing software (e.g., lab equipment)

karel@kapaji.eu, pavel@kapaji.eu, jiri@kapaji.eu, nebo kapaji@kapaji.eu

Kapaji s.r.o. | Litevská 1174/8 | 100 00 Praha 10 – Vršovice

  C 303419 vedená u Městského soudu v Praze | IČO 076 19 332|DIČ CZ07619332

  • LinkedIn Social Icon