Assisting companies with pharmaceutical ingredient compliance solutions is a key cornerstone of Labtopia’s business. The specialty chemical industry is under unique pressures to meet increasing regulatory requirements all the while supplying products to a wide variety of different industries. Labtopia’s founders understand the pressures of the pharmaceutical ingredient manufacture and have the background in specialty chemical manufacturing and quality assurance to implement pharmaceutical excipient quality systems that meet the requirements of the pharma industry without placing unnecessary burden on the excipient manufacturer.
Labtopia’s key services for the pharmaceutical ingredients industry includes:
- IPEC GMP Gap Assessments
- IPEC GMP Audits
- Development of IPEC GMP Quality Systems
- Independent Third-Party GMP Audits
- Preparation for Third-Party Certification (IPEA, USP-Verified)
- IPEC GMP Training
- EFfCI Audits and GAP Assessments
- EXCiPact Audits and GAP Assessments
- ISO 13485
Labtopia stays abreast of current pharmaceutical ingredient compliance requirements through membership in the International Pharmaceutical Excipient Council of the Americas (IPEC-Americas). In addition, Labtopia has provided global pharmaceutical excipient audits conducted against IPEC GMP guidelines to Univar since 2007. Labtopia’s auditors have been instrumental in developing the Univar excipient audit library based the IPEC:PQG audit guide. More information about Univar’s excipient library and the independent, third-party excipient audits can be found by visiting the Univar website.
In addition, Labtopia provides standard professional services for pharmaceutical GMP compliance such as:
- Regulatory Consulting Services
- Technical Writing Services
- Process Validation Protocols
- Software Validation Protocols
- Quality Systems Procedures
- Operations Procedures
- Good Manufacturing Practices
- GMP Laboratory Fundamentals
Additionally, Labtopia is able to provide comprehensive technical and scientific support within the pharma ingredients industry.
- Labtopia Staffing provides staffing and recruiting services for engineers, laboratory and quality personnel.
- Laboratory Informatix provides informatics services for planning, development and implementation of quality related databases, such as LIMS, customer complaint systems, training systems and corrective and preventive action systems.
- Labtopia Training provides a full slate of training courses designed for management and technical personnel.