assessment of the transfer of technology and analytical...

Assessment of the transfer of technology and analytical techniques

Zdenek Pavelek08 / 2018

Assessment of the transfer of technology and analytical techniques

• at the end of the transfer, it is recommended to evaluate the received status and readiness for routine production / control

• the evaluation can be performed before• a report on the transfer• start-up of routine production / control

• the transfer estimate usually includes• revision of documentation• audit of readiness for routine production / control

Revision of documentation

• It is usually carried out for the following transport stages• Transfer preparation and planning• Transfer of analytical methods• Putting into operation starting and packaging materials• Production Unit Preparation• Transfer of production and packaging processes• Introducing of cleaning processes• Product Implementation• Completion of the transfer procedure• Changes in the registration documentation

Revision of documentation1. Transfer preparation and planning

• The revision is• Quality agreement of technology transfer• Technology Transfer Project Plan• Quality plan for the technology transfer project• Risk analysis of technology transfer• GAP analysis• Protocol (s) for individual transfers

• It is considered• The list of documents• Issuance and approval of documents of the sending and receiving units (SU / RU)• Change control of

• project• documents

Revision of documentation2. Transfer of analytical methods• Revision of all transference protocols

• finished dosage forms, API• excipients• API residuals

• It is considered• issue of the document and its approval by both parties – SU / RU• accessibility of all

• standards• samples• instruments and instruments (columns)• reagents

• personnel training

Revision of documentation2. Transfer of analytical methods• Revision of raw data and reports• It is considered

• issuing of the documents and its approval by both parties – SU / RU• procedure for analysis and use

• standards• samples• instruments and instruments (columns)• reagents

• records and data• availability (archiving) and completeness• correctness and accuracy of calculations• investigation of OOS results, deviations or changes

• results and compliance with acceptance criteria• comparison of results with documentation

• on validation of analytical methods• transferring party (development report, trend analysis)

Revision of documentation3. Putting into operation starting and packaging materials• Review of the specifications is carried out for

• AFI• Excipients• primary packaging materials• secondary packaging materials• technical materials (detergents, solvents, etc.)

• It is considered• inclusion in internal systems

• EPR• LIMS• documentation (EDMS)

• compliance with the registration documentation / SU• implementation of proposed changes of

• manufacturer• parameters

Revision of documentation3. Putting into operation starting and packaging materials• If the API changes are considered

• manufacturer and supplier chain• synthesis and production process

• raw materials, intermediates, solvents

• critical steps and control operations

• physical, chemical and microbiological properties of the API• Impuritiy profile (degradation products, inclusions and concentration levels)• stability (storage conditions, re-testing time / shelf life)• requirements for safety and handling

(MSDS - Material Safety Data Sheet)

Revision of documentation3. Putting into operation starting and packaging materials• When the excipients are changed

• manufacturer and supplier chain

• excipient‘s characterization• functionality in dosage form (MP)

• impact on BE

• physical, chemical and microbiological properties of the excipient

• stability (re-testing time / shelf-life) requirements for safety and handling(MSDS - Material Safety Data Sheet)

Revision of documentation4. Подготовка производственной единицы• The revision of

• Design documentation• Comparison of equipment and systems

of the sending and receiving units (SU / RU) (GAP-analysis)• Protocols and reports on DQ, IQ, OQ, PQ

• Equipment• support systems

• HVAC and clean rooms• water systems (PW / WFI)• clean steam system• compressed gases (CA / CN)• heating and cooling systems

• computerized systems (EPR, LIMS, MES, EDMS, ...)

Revision of documentation4. Подготовка производственной единицы• It is considered

• maintenance and service documentation• manuals, instructions• log-books• working plans, records, reports• monitoring records and reports

• validation documentation (DQ, IQ, OQ, PQ)• issue and approval of documents• compliance with acceptance criteria• investigation of deviations, OOS results, changes in validation

• related actions• CAPA• change control procedure

Revision of documentation5. Transfer of production and packaging processes• Revision of documentation of sending unit (SU) performed for

• Process development• Summary information for series on stability and development• PV (protocol, report)• PQR (Product Quality Review)

• It is considered• availability and consistency of documentation

• issue and approval of documents• compliance with acceptance criteria• investigation of deviations, OOS results, changes, complaints• trend analysis

• compliance with obligations• CAPA• change control procedure

Revision of documentation5. Transfer of production and packaging processes• Revision of documentation of receiving unit (RU) performed for

• Transfer Technology Protocols• Instruction of production / packaging + MBR• Batch records of production / packaging (BRs)• SOPs, instructions• PV protocol and report• Personnel training records

• It is considered• implementaion into internal systems

• MES• documentation (EDMS)

• compliance with the documentation of the sending unit (SU) and registration• implementation of proposed changes of

• process• equipment• parameters

Revision of documentation5. Transfer of production and packaging processes• The revision of raw data and reports of receiving unit (RU)• It is considered

• issue of the document and its approval by both parties• flow diagram and application of

• materials• equipment• systems

• records and data• availability (archiving) and completeness• correctness and accuracy of calculations• investigation of deviations or changes

• results and compliance with acceptance criteria• comparison of results with documentation

• PV• Sending unit (for development, trend analysis)

Revision of documentation6. Introducing of cleaning processes• Revision of documentation sending unit (SU)

• Cleaning procedure

• Validation protocols and reports of cleaning validation (CV)• Reports on monitoring of equipment cleanness




Revision of documentation6. Introducing of cleaning processes• Revision of documentation receiving unit (RU) for

• Process development• Process validation• Process revalidation/verification




Revision of documentation7. Product Implementation• Revision of documentation receiving unit (RU) for

• Specifications of IM, IBP and MP• Analytical methods• Personnel training records• Protocol and stability study report (ongoing stability study)

• It is considered• implementation into internal systems

• LIMS• documentation (EDMS)

• compliance with the documentation of the sending unit (SU) and registration• implementation of proposed changes

• components• parameters

Revision of documentation7. Product Implementation• Verification of the stability study conditions

• number and composition of MP series• AFI• excipients• primary packaging materials

• conditions and storage time (25°C / 60%, 40°C / 75%, 30°C / 65%)• number of samples, storage method• sampling and analysis

• It is considered• implementation into internal systems

• LIMS• documentation (EDMS)

• compliance with the documentation of the sending unit (SU) and registration• verification of changes

Revision of documentation8. Завершение переноса• The review is conducted on

• Consolidated report on the transfer of technology• Report (s) for individual transfers• Protocols / Reports about

• deviations, OOS• CAPAs• Changes

• Internal documentation (entered)• It is considered

• the list of documents• issue and approval of documents of the receiving unit (RU)• status of

• deviations, OOS• CAPAs• changes

Revision of documentation8. Завершение переноса• Review of the issued documentation

• Materials• Specifications (RM, PM, IBP, FP, ...)• BOM

• instructions and records of• Production• Cleaning

• instructions for systems and equipment• Service• Maintenance

• SOPs• It is considered

• issue and approval of documents• personnel training• availability at the place of application

Revision of documentation9. Changes in the registration documentation• Revision of documentation before registration change of

• Specifications• Analytical methods• Production process (and/or MBR)• Process validation• Stability study

• It is considered• issue and approval of documents• compliance with documentation• execution of obligations• compliance with internal documentation

Audit of readiness for routine production

• Before starting a routine production, it is recommended that an audit be conducted to check the preparedness of all departments

• Research and development• Logistics• Production• Maintenance / engineering / qualification• Quality control• QC / QA / Compliance• Validation• Regulatory Affair(RA)

Audit of readiness for routine production

• The purpose of the audit is to check all processes and documentation related to routine production

• purchase of RM/PM• receiving of RM/PM• quarantine and sampling of RM/PM• storage of RM/PM• manufacture of IBP• MP filling• MP packaging• QC testing• documentation review and investigation of deviations by QA • QP releqsing• MP storage

assessment of the transfer of technology and analytical...

Documents