Alban ARSENE
 
C4PMD CEO and Founder

30 years of background in operations, processes, products, facilities and supply chain within pharmaceutical industry; aseptic, sterile process and medical devices class III.

Strong knowledges of FDA rules regarding cGMP's (21CFR 210,211,820) & MDSAP audit program. Global engineering and start-up of factory buildings.

Project#1 : equipment implementation

How C4PMD  handle technical projects?

 

Industrial master plan based on the 4 pillars

  1. by Design : Product process expectations
  2. by Quality : Product quality expectations
  3. by Regulatory : Product regulatory expectations
  4. by Manufacturing : Product manufacturing expectations

Project PMO

  1. project management
  2. Costs and schedule
  3. Project implementation

Equipment implementation 

  1. Process risk analyses
  2. Design review of the equipment  
  3. Factory Acceptance Test (FAT): Test capitalisation
  4. Installation Qualification
  5. Operational Qualification
  6. Process validation

 

Release to production

Steam sterilizator

Hyaluronic Acid filling station

Project#2 : Iso 17665-1 remediation

How to sterilize thermolabile product as hyaluronic acid pre-filled syringes?

Sterilization for a thermolabile product is very challenging. 

For assuming the day to day the Sterility Assurance Level of a medical device or a parenteral drug, legal manufacturer should follow the ISO 17665-1 norm

C4PMD is your expert, for the sterilization validation up to the release to production.

C4PMD will support te legal manufacturer.

Validation strategy 

  • Validation master plan
  • Qualification of the sterilizer
  • Process validation for the sterilisation itself
  • Sterilization validation report with the SAL
  • Validation summary report

 

C4PMD offer a consistant training about the sterilization validation in accordance with the ISO 17665-1:

  • Sterilization basic concept
  • Sterilization detail concept
  • Validation strategy
  • D value & Z value
  • Bioligical Indicators
  • SAL calculations

 

 

Steam sterilizator

Sterilization training

Project#3 : DHF remediation

Manufacturing process validation

Design transfert remediation in accordance with MDR 2017/45 

Validation prospective in accordance with a retrospective manufacturing data available

C4PMD is your expert, for the manufacturing process validation 

C4PMD will support te legal manufacturer.

Validation strategy 

  • Validation master plan
  • Process risk analyses
  • Worst case challenge definition as output of the process risk analyse
  • OQ process protocol with worst cases challenges 
  • PQ process portocol as routine manufacturing batches
  • Cpk and Ppk evaluation thanks to Minitab software
  • Validation summary report

 

 

 

 

Cpk & Ppk manufacturing process validation

C4PMD : your expert in life sciences 

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