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Validation and qualification

Validation is a systematic method used to confirm that a specific process, system, or equipment consistently meets predetermined specifications that meet quality criteria. Our engineers have a deep understanding of validation protocols, covering all steps from initial design to commissioning and ongoing operational production. This includes accounting for the critical process parameters of the process and the implementation of rigorous testing regimes against the predetermined specifications, and the clear documentation of results, all leading to the formal verification of process robustness.

In addition to this, Qualification is a crucial part of the pharmaceutical industry, ensuring that equipment and systems operate according to predefined requirements. Our engineers demonstrate exceptional skills in implementing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, while thoroughly examining every aspect of equipment functionality and process performance. This includes the validation of critical utility systems, including Clean Utility and Black Utility networks, to verify their compliance with the strict criteria set by regulatory authorities.

Our specialists are skilled in aligning Validation and Qualification processes with current regulatory frameworks, including the cGMP (current Good Manufacturing Practice) guidelines issued by regulatory authorities such as the FDA and EMA. They have a thorough awareness of the changing landscape of regulatory standards, ensuring that our clients remain at the forefront of compliance.

Along with these core competencies, our engineers have a wealth of practical experience in carrying out validation and qualification exercises across a wide range of pharmaceutical facilities and equipment. This includes both traditional pharmaceutical manufacturing processes and emerging technologies in the field of medical devices, ensuring a comprehensive and adaptable approach to compliance.

In conclusion, our consultancy boasts an unmatched depth of expertise in Validation and Qualification processes, supported by the exceptional proficiency of our engineers. Through our seasoned expertise, we enable pharmaceutical manufacturers and medical device developers to navigate the complexities of regulatory compliance with precision and effectiveness, ultimately leading to the production of therapeutics and medical devices of the highest standard.

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We strive to implement simple and operational solutions, and can support the implementation of procedures and training activities that ensure compliance with existing authority requirements and inspection readiness.

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Fermentation and recovery
Purification
Clean utility
Black utility
Process automation / IT Backbone
Validation and qualification
General optimization & project management

Validation and qualification cases

Implementation of program changes to make receive and storage tanks for impure ethanol (ARS)
Roles as Project manager and OR, Change request, VPL, update and approval of design documents. Writer and approver of DQR and OVR. SOP updates and training of end users.
CIP/SIP project (CB)
SIP: Cycle development and PQ of new production facility equipment CPE (closure processing equipment) for new filling factory, writing protocols, participating in execution and writing reports. DQ, FAT, SAT of new production facility for both process and CIP/SIP processes. Participation in design of equipment and in design of automation system to the new production equipment. Review of FDS’s, participation in FAT and SAT of automation system for the downstream process, the CIP process and the SIP process. Making the CIP/SIP qualification strategy. Writing OQ and PQ protocols. URS, DQ, FAT, IQ, OQ of new autoclaves and utensil washer. Participation in design process to DQ over FAT to the IQ and OQ. Making reviews, writing protocols and physical participation in FAT. SIP PQ of new process upstream facility: planning and execution of the SIP. Making qualification strategy, writing rationales, VPP, procotols.
Demand driven CIP and better regenerative heat exchangers on ethanol columns (ARS)
Roles as primary user and OR, Change request, VPL, update and approval of requirement documents and design documents. Writer and approver of DQR, IVR and OVR. SOP updates and training of end users. Final verification of the change.
Move of NN729 reg. EtOH distillations process from old distillations column to new (ARS)
Roles as project manager and OR, Change request responsible, risk evaluation, planning and writer/approver of VPL, IVP/R, OVP/R and PFV phase 2 and 3 protocols and reports. Updates of SOP and training of operators and supporters.
Reduction of ZA waste to M-onsu waste, and use of the waste for distillation (ARS)
Roles as primary user, project manager and OR, Change request responsible, risk evaluation, planning and writer/approver of VPL, OVP/R and PFV phase 1, 2 and 3 protocols and reports, with hands on running of the ethanol column including sampling. Updates of SOP and training of operators and supporters.
New defoamer unit for distillation columns (ARS)
Roles as primary user, project manager and OR, Change request responsible, risk evaluation, planning and writer/approver of VPL, OVP/R and PFV phase 1, 2 and 3 protocols and reports, with hands on running of the ethanol column including sampling. Updates of SOP and training of operators and supporters.
Sampling units for distillation columns (ARS)
Roles as primary user and OR, Change request, VPL, update and approval of requirement documents and design documents. Writer and approver of DQR, FAT, SAT, IVR and OVR. SOP updates and training of end users. Final verification of the change.
Minimizing bleed off amount in distillations columns without compromising quality of regenerated ethanol (ARS)
Roles as Project manager and OR, Change request responsible, risk evaluation, planning and writer/approver of VPL, OVP/R and PFV phase 1, 2 and 3 protocols and reports, with hands on running of the ethanol column including sampling. Updates of SOP and training of operators and supporters.
Clean room qualification (JKA)
Sterility Assurance Project. Construction of new production facility compliant with Annex 1 requirements. Track lead on cleanroom qualification. Overseeing integration of new building into existing building including HVAC qualification.
Clean room qualification (JKA)
Construction of new facility for production of devices requiring ISO class 8 production rooms. Performing qualification of production rooms.
Automatic raw material concentration calculation in PCS system (LT)
Project Manager, primary user, validation, and change request responsibilities: Documentation included URS, risk evaluations, DER, DQ, XQ. Author and approval of SOP, JI, and JTP (TROL) used for training of operators.
Qualification of production autoclaves (LT)
Primary user and validation responsibilities including ER/OR-roles. Approval of SQP, supplier visits, URS, risk evaluations, traceability matrix (CARA), DER, DQ, construction controls, FAT, SAT, IQ, OQ, PQ. Author of maintenance plans, SOP, JI and JTP (TROL) used for training of supporters and operators.
Qualification of warehouse freezer (LT)
Primary user and validation responsibilities including ER/OR-roles. Approval of URS, risk evaluations, DQ, IQ, OQ, and PQ. Author of maintenance plans, logbooks, SOP, JI, and JTP (TROL) used for training.
Production plant qualification (SS)
IQ, OQ qualification of HDM Production plants for ALK with NNE as vendor working as an automation expert and support for customer.
Implementation of program changes to make receive and storage tanks for impure ethanol (ARS)
Roles as Project manager and OR, Change request, VPL, update and approval of design documents. Writer and approver of DQR and OVR. SOP updates and training of end users.
CIP/SIP project (CB)
SIP: Cycle development and PQ of new production facility equipment CPE (closure processing equipment) for new filling factory, writing protocols, participating in execution and writing reports. DQ, FAT, SAT of new production facility for both process and CIP/SIP processes. Participation in design of equipment and in design of automation system to the new production equipment. Review of FDS’s, participation in FAT and SAT of automation system for the downstream process, the CIP process and the SIP process. Making the CIP/SIP qualification strategy. Writing OQ and PQ protocols. URS, DQ, FAT, IQ, OQ of new autoclaves and utensil washer. Participation in design process to DQ over FAT to the IQ and OQ. Making reviews, writing protocols and physical participation in FAT. SIP PQ of new process upstream facility: planning and execution of the SIP. Making qualification strategy, writing rationales, VPP, procotols.
Demand driven CIP and better regenerative heat exchangers on ethanol columns (ARS)
Roles as primary user and OR, Change request, VPL, update and approval of requirement documents and design documents. Writer and approver of DQR, IVR and OVR. SOP updates and training of end users. Final verification of the change.
Move of NN729 reg. EtOH distillations process from old distillations column to new (ARS)
Roles as project manager and OR, Change request responsible, risk evaluation, planning and writer/approver of VPL, IVP/R, OVP/R and PFV phase 2 and 3 protocols and reports. Updates of SOP and training of operators and supporters.
Reduction of ZA waste to M-onsu waste, and use of the waste for distillation (ARS)
Roles as primary user, project manager and OR, Change request responsible, risk evaluation, planning and writer/approver of VPL, OVP/R and PFV phase 1, 2 and 3 protocols and reports, with hands on running of the ethanol column including sampling. Updates of SOP and training of operators and supporters.
New defoamer unit for distillation columns (ARS)
Roles as primary user, project manager and OR, Change request responsible, risk evaluation, planning and writer/approver of VPL, OVP/R and PFV phase 1, 2 and 3 protocols and reports, with hands on running of the ethanol column including sampling. Updates of SOP and training of operators and supporters.
Sampling units for distillation columns (ARS)
Roles as primary user and OR, Change request, VPL, update and approval of requirement documents and design documents. Writer and approver of DQR, FAT, SAT, IVR and OVR. SOP updates and training of end users. Final verification of the change.
Minimizing bleed off amount in distillations columns without compromising quality of regenerated ethanol (ARS)
Roles as Project manager and OR, Change request responsible, risk evaluation, planning and writer/approver of VPL, OVP/R and PFV phase 1, 2 and 3 protocols and reports, with hands on running of the ethanol column including sampling. Updates of SOP and training of operators and supporters.
Clean room qualification (JKA)
Sterility Assurance Project. Construction of new production facility compliant with Annex 1 requirements. Track lead on cleanroom qualification. Overseeing integration of new building into existing building including HVAC qualification.
Clean room qualification (JKA)
Construction of new facility for production of devices requiring ISO class 8 production rooms. Performing qualification of production rooms.
Automatic raw material concentration calculation in PCS system (LT)
Project Manager, primary user, validation, and change request responsibilities: Documentation included URS, risk evaluations, DER, DQ, XQ. Author and approval of SOP, JI, and JTP (TROL) used for training of operators.
Qualification of production autoclaves (LT)
Primary user and validation responsibilities including ER/OR-roles. Approval of SQP, supplier visits, URS, risk evaluations, traceability matrix (CARA), DER, DQ, construction controls, FAT, SAT, IQ, OQ, PQ. Author of maintenance plans, SOP, JI and JTP (TROL) used for training of supporters and operators.
Qualification of warehouse freezer (LT)
Primary user and validation responsibilities including ER/OR-roles. Approval of URS, risk evaluations, DQ, IQ, OQ, and PQ. Author of maintenance plans, logbooks, SOP, JI, and JTP (TROL) used for training.
Production plant qualification (SS)
IQ, OQ qualification of HDM Production plants for ALK with NNE as vendor working as an automation expert and support for customer.

Validation and qualification profiles

Aseptic production
Cleaning
GMP
Quality
See profile and CV

Reab Jaralla

Process Engineering Consultant
Sema has more than 12 years of experience in the pharmaceutical industry. Working in Xellia with different roles from Compliance specialist, production specialist, GMP documentation specialist, Senior Aseptic processing specialist, has made Sema an experience all round profile around the aseptic processing disciplines.
GMP
Qualification & Validation
Quality
See profile and CV

Sema Oruc

Process Sr. Consultant
Mikael is an experienced person (>15 years) within the pharmaceutical industry who is used to working according to cGMP, working in project form with both leading, driving and being involved in projects and has experience in supporting and leading employees in production.
GMP
Project management
Qualification & Validation
Technology
See profile and CV

Mikael Samuelsson

Process Specialist
John is a multi-disciplined Engineer with much international experience (Switzerland, Germany, Denmark, The Netherlands, Ireland, Australia).
Documentation Generation
Programming
Technology
See profile and CV

John Thornton

CQV/Automation Specialist
Jonas is a self-driven yellow/red Insight profile with the ability to support your engineering needs. Jonas has a degree in Mechanical Engineering, with a speciality in mechanical construction, and a proven track record from a danish machine builder.
Data Driven
Mechanical Engineering/Design
Open minded
See profile and CV

Jonas Højslet

Senior Consultant
Søren has a wide range of competences acquired through more than 20 years of experience from Pharma and life science projects and manufacturing.
GMP
Line & project execution
Personal
Technology
See profile and CV

Søren Wamsler Christiansen

Senior Consultant
See all employees

Managing Partner in Process Engineering

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Jonas Højslet

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