Confidence Beyond Compliance
Pharmaceutical batch sizes manufactured to support the NDA or ANDA license application are typically scaled up to larger batch sizes after approval.
FDA Scale-up and Post Approval Changes (SUPAC) guidance provides recommendations to product license holders on scale-up of the process and making a change to the site of manufacture or testing post NDA or ANDA approval. Scale-up activities should be managed under the Pharmaceutical Quality System (ICH Q10).
Also, current regulations and FDA Technology Transfer best practice standards demand that any transfer of a technology as required to support SUPAC to the CMC documentation, is managed under the Pharmaceutical Quality System.
PharmaLex’s team of experts, which includes a number of former EU regulators, have the experience and expertise to provide support services to your scale-up operations, including:
- Working with Technical Services, Validation, Manufacturing Operations and Regulatory to
- identify changes to the manufacturing process, equipment, or site of manufacturing or testing to scale-up the batch size
- assess the changes required as Major, Moderate or Minor, in accordance with regulatory guidance
- advise on regulatory filing procedures based on the category of the changes, i.e. For US, Prior Approval supplement, Changes Being Affected supplement or Annual reportable; for EU Type 1 or Type 2 variation
- advise your SMEs on validations and/or release testing to be performed in order to confirm successful scale-up (or down) of batch size, and any Technical Transfer activities employed as part of the scale-up process.
- Providing guidance and support on preparation of scale-up documentation, including protocols which
- define the scale-up activities
- assign roles and responsibilities
- document performance of validations and/or release testing to confirm successful scale-up (or down) of batch size, and any Technology Transfer activities employed as part of the scale-up process
- apply Risk Management principles to the scale-up operation
- describe performing the scale-up under the management of the Pharmaceutical Quality System, including management of documentation, change control, deviation investigations and CAPA management
- require appropriate sign off/approval by relevant parties and by Quality on completion of the scale-up protocol
- and scale-up reports, including associated records of actions taken or conclusions reached as part of the Scale-up activities
- Providing support in the management of scale-up projects, whether within-site or inter-site, and incorporating Technology Transfer activities, to
- ensure that the key milestones of the project are identified
- ensure that the challenges to the scale-up process are identified
- ensure the application of Quality Risk Management to the process
- ensure that the scale-up process is completed effectively, efficiently and meets regulatory expectations and compliance.
Providing training on scale-up activities in compliance with GMP and regulatory guidance.
- Computer System Validation (CSV)
- Digital Health Questionnaire
- GxP Services
- Interim / Contract QA
- Literature Monitoring & Screening
- Regulatory Operations
- SMART MDR
- SMARTCHECK MDR
- SMARTENOVAL – analytical method validation software
- SMARTSEELVA – bioassay validation software
- SMARTSTABELITY – product stability and shelf-life estimation software
- SMARTTRANSVAL – analytical method transfer software
- Statistical Services
- Technology Enabled Services
What our clients say
We needed to develop our strategy and PharmaLex had exactly the experience we needed.
Senior QA Director
Pharmalex provided the resources we needed to compile Investigational Medicinal Product Dossiers for our biological products. The dossiers were delivered on time with the trusted quality we expected
Sr Director Regulatory Affairs CMC