Even the best Quality Management Systems may have occasional gaps. These, in our experience, could be either due to work load, new legislation or staff shortages.
Ask for Pharma Solutions have experience, that can be used to help plug those gaps. We are available all hours to facilitate round the clock support, or able to work on specific systems for a specified period.
Our round the clock service ensures you have QA on site in your 24h facility when you sleep; supporting manufacturing and handing over to QA staff when they arrive in the morning.
We can work on specific projects such as:
1- The implementation of Equipment Qualification, Computer, Process validation
2- New Product Introduction
We can carry out essential checks for existing or new processes, products and suppliers. Our auditing approach could be tailored to match European or American or ISO standards and gives a fresh perspective that could identify aspects that may have been genuinely overlooked.
Involving Ask for Pharma Solutions hence helps make the difference to:
1- Regulatory File Compliance Checks & Gap Resolution
2- Auditing Third party Manufacturers
3- Auditing API suppliers
4- Auditing other starting material (packaging suppliers)
5- Preparation for or Support during Regulatory Inspections
6- Carrying out Self Inspections and completing your annual commitments
7- Writing Technical or Quality Agreements
We can act as additional support in the implementation of your Quality System
1- Quality Systems design: Mapping out your systems and ensuring the associated documents are integrated and implementing agreed corrective actions
2- Quality Documentation: Writing SOPs to cover gaps in the Quality Management System or amending SOPs in accordance with established systems. In addition we can write Quality Manuals, Site Master Files, Validation Master Plans, Validation Protocols, Validation Summary Reports, Manufacturing or Packaging batch documents
3- Quality Improvement Plan (QIP) Proposals & Implementation: Working with Quality Managers or QPs to devise QIPs based on data and facilitate implementation/ training where required
3- Failure Investigation (Deviations and Out of Specifications): Acting as facilitator or implementation of structured Root Cause Analysis to know why anomalous events occurred. Ensuring a scientific approach and analytical means of reaching the root cause(s) and sound rationale for risk assessment that allows effective decision making
4- Design of Risk Management Processes and carrying out Risk Assessments
5- Design and Management of Corrective Actions and Preventative Actions (CAPA) Systems: Either help design a system from scratch or help maintain existing approaches to implementing actions and ensuring effectiveness of solutions to prevent repeat incidences and reducing waste
6- Product Quality Reviews (PQRs): Carrying out and documenting comprehensive PQRs which seeks to assess process capability and statistical evaluation of historical data; allowing effective decision making for the future of a successful product and robust processes