GMP Compliance
We offer
Inspection readiness
Equipment / building qualification
Planning and executing the qualification and validation process is often a significant and complex component of a larger project that may require substantial resources.
Qualification and validation documentation is often reviewed during audits by authorities or customers. Therefore, it is essential that all aspects of the new premises, equipment and processes are thoroughly covered.
At the same time, it is essential to prevent errors that could endanger patient safety and result in substantial costs for the company.
At ITH Pharma ApS we have experience in qualifying and validating projects of various sizes. We create a customised plan based on your organisation's structure and working procedures.
The approach to the qualification and validation process may differ depending on the equipment's risk profile. This may involve thorough qualification following the V model or a risk-based approach, where key elements are qualified based on a risk assessment.
We have particular expertise in production and warehouse equipment and facilities.
Typical assignments including:
- Project management and engagement of relevant stakeholders
- Training staff to ensure tests are conducted according to the test protocol
- Conducting test phases
- Change Control
- Risk assessments
- User Requirements Specifications (URS)
- Validation master plan
- Associated test phases
- Cooperation with the company about test protocols and reports
Contact us today to discuss how we can assist you in ensuring the success of your qualification and validation processes.
Our expertise can assist you in minimising risks, ensuring stringent GMP compliance, safeguarding patient safety and maintaining business continuity.
Internal auditing
Let us assist you in meeting the expectations of authorities and customers with compliance.
Internal audits are essential for overseeing the implementation and adherence to relevant GMP regulations for finished products and APIs.
The purpose of internal audits is to:
- Identify errors and shortcoming
- Ensure compliance with applicable instructions
- Evaluate the need for changes in the quality system
- Minimise risks and ensure patient safety
- Prepare the company for external inspections by authorities and customers
At ITH Pharma ApS, we have extensive practical experience in conducting internal audits and providing support during audits. We offer:
- Routine reviews of GMP/GDP status within a department
- Planning, conducting and reporting on internal audits
- Follow-up on observations and deviations identified during audits
- Mock inspections of production and packaging facilities and warehouse premises
- Development of improvement plans and action plans based on audit findings
- Training staff in GMP/GDP principles and audit preparation
By conducting regular internal audits, we ensure that your organisation consistently maintains high quality, meets regulatory requirements and upholds a strong compliance culture that protects both patient safety and your reputation.
Get in touch with us for an informal discussion about how we can help you.
Inspection readiness
Let us guide you through the complexities of inspections
Being involved in the life science industry means that it is essential to maintain §39 manufacturer licenses and other relevant permits. By law, suppliers must undergo continuous inspections by regulatory agencies and customers. Therefore, your entire organization must be prepared for inspections well in advance, not just on the day of the inspection.
While many consultancies concentrate solely on quality documentation, we also address the practical aspects. Our experience is that there is often a shortage of time and resources due to a focus on daily operations.
With our extensive practical experience, we can assist both at the departmental level and across the entire organisation. Engaging employees and departments not only demonstrates inspection readiness but also builds credibility with inspectors, leading to a smoother inspection process with fewer deviations.
We offer:
- Preparation of an inspection plan with QA and/or locally for the department
- Demonstration af ’Do & Don’ts’ for personalet
- Training in staff behaviour
- Ensuring inspection-ready environments
- Presentation techniques
- Presence of appropriate expertise during the inspection
- Provision of the 'inspection readiness' playbook
Value for the customer:
- Freeing up resources for operations
- Fewer deviations, resulting in economic benefits
- Enhanced reputation
- Increased safety for employees
- Greater credibility with authorities and customers
- Boosted motivation among employees and within the organisation
We can also be involved in the inspection as a facilitator, assistant, back-office support or by managing follow-up and documentation tasks.
Contact us to discuss how we can assist you.
Product and cleaning validations
We provide reliable support for product and cleaning validation
When developing a new product, it must first be validated on commercial equipment with a specified number of batches. This validation process is often followed by a tight timeline and any failure of the validation batches or delays in meeting the product launch date may have significant economic impacts for the company.
With our extensive practical experience in starting up factories with new equipment, optimizing production facilities and ongoing product verification, we have significant expertise in the relocation and subsequent validation of products in:
- Liquid API
- Micro-encapsulated vitamins
- Tablet production, including both manufacturing and finishing stages
Our deep understanding of processes enhances the effectiveness of process validation, whether it involves product validation or equipment cleaning validation.
We serve as a reliable resource for:
- Scaling up batch sizes
- Product validation for both manufacturing and finished products
- Cleaning validation for equipment and facilities
We understand the significance of these processes and are therefore available to support validation activities that involve shift work or weekend operations.
Contact us to find out how we can be incorporated into your validation strategy.