GL Technologies (formerly Calibration Consultants) is a full service calibration provider specializing in the Biopharmaceutical and Medical Device industries. Our management has worked in, managed, and developed FDA cGMP fully compliant programs. Our services include roving crews for the Biopharmaceuticals for regular scheduled calibrations or shutdown and new system situations. GL Technologies also places qualified individuals on various large and small Biopharmaceutical and Medical Device companies. The services we provide include general Calibration/ Metrology support, asset and CMMS management, compliant program development, SOP development, and maintenance/ facilities support.
GL Technologies can fully setup a compliant program including method development, Identification of items to calibrate in a facility or on a system, tolerance assignment, calibration cycle determination, and SOP design. Our management has personally been audited by and developed programs that have been audited by the FDA, FDB, European, and Asian Regulatory Authorities. We specialize in the placement of personnel on sites and are often used to vet potential new hires for Biopharmaceutical and Medical Device companies. GL Technologies has placed over 180 individuals at sites in California and abroad. There are no fees or penalties for the full time hiring of these individuals. Most of the current CA Biopharmaceutical programs are now managed and staffed by former GL team members. We serve all of California with clients in San Diego, Los Angeles, San Francisco, Orange County, and Riverside.
Frequently Asked Questions
What are the different calibration standards used in HPLC?
In HPLC (high performance liquid chromatography), various calibration standards are used to verify accurate and reliable analysis. A common standard is the external standard method where a known concentration of a pure compound is prepared separately and analyzed alongside the sample. This method determines retention time and peak area for quantification. Another approach is the internal standard method, where a known amount of an internal standard is added to both the sample and calibration standards to account for variations in sample preparation and instrument performance. Calibration curves using multiple concentration levels are also used to establish the relationship between concentration and response. These standards may be prepared from pure compounds or certified reference materials, ensuring accurate and reliable quantitative analysis.
What are the acceptance criteria for HPLC calibration?
Acceptance criteria for HPLC calibration ensure accuracy and reliability of instrument performance. These criteria vary by laboratory and regulatory requirements but typically include system suitability, retention time consistency, peak symmetry, resolution, linearity, accuracy, and sensitivity. System suitability tests confirm the HPLC system operates within acceptable limits. Retention time and peak symmetry ensure reproducible analyte elution, while linearity verifies response across concentration ranges. Accuracy and sensitivity confirm the system can produce repeatable and detectable results. Meeting these criteria validates the calibration and reliability of analytical results.
Are there any regulatory requirements for HPLC calibration?
Yes, regulatory requirements exist for HPLC calibration. Agencies such as the FDA and ICH mandate regular calibration of HPLC systems used in pharmaceutical and other regulated industries. These requirements ensure accuracy, traceability, and reliability of analytical results. Proper calibration, qualification, and maintenance must be documented through instrument logs, calibration certificates, and standard operating procedures. This documentation is essential for regulatory compliance, inspections, and audits.
What documentation is required for HPLC calibration?
Required documentation for HPLC calibration includes a calibration plan outlining procedures and parameters, an instrument qualification report confirming compliance with acceptance criteria, and a calibration log documenting dates, results, and reference materials used. Any deviations or incidents encountered during calibration must also be recorded in deviation or incident reports along with corrective actions taken. Together, these documents provide traceability, compliance evidence, and long-term quality assurance.
What is Operational Qualification (OQ), and what does it involve?
Operational Qualification (OQ) is a validation phase that verifies equipment or systems operate according to intended functions within predefined operational parameters. OQ involves documented tests such as performance testing, calibration verification, functional checks, and documentation review. These activities confirm compliance with specifications and regulatory requirements, ensuring reliable and consistent operation that supports product quality and safety.
Are there any specific regulations or guidelines that outline the requirements for IQ, OQ, and PQ?
Yes, regulations and guidelines outline requirements for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Regulatory bodies such as the FDA and ISO provide guidance defining the scope, objectives, test protocols, acceptance criteria, and documentation needed for each qualification. These frameworks ensure equipment and processes are validated to meet predefined standards and perform consistently in regulated environments.
About GL Technologies
GL Technologies, based in San Diego, is a specialized service provider catering to the highly regulated industries of biopharmaceuticals, pharmaceuticals, medical devices, and government sectors. The company focuses on delivering expert solutions in equipment calibration, validation, and compliance services, ensuring that clients meet stringent GMP (Good Manufacturing Practice) and FDA regulations. GL technologies is a trusted partner from commissioning new plants to decommissioning with compliance. GL can place dedicated motivated quality personnel on site anywhere. A program can be designed or revamped for the customers needs from design of CMMS to SOP development, specification development and performance of calibrations.
With a dedicated team of 29 technicians, GL Technologies offers precision calibration, preventative maintenance, and qualification services for laboratory and production equipment used in critical manufacturing and research processes. The company’s expertise is supporting its clients in maintaining regulatory compliance and operational efficiency.
As a full-service company specializing in equipment calibration, repair, and certification services for biopharmaceutical, pharmaceutical, and medical device industries. Our team has extensive experience working with sPRT calibrations along with CMMS software, HPLC OQ validation, and fume hood certifications. Companies of all sizes rely on our team to implement, maintain, and keep their research and manufacturing processes compliant with regulatory standards. Other specialties include building maintenance systems, and mass spectrometry calibrations. GL Tec specializes in IQ OQ PQ services for clients throughout San Diego, San Francisco, Los Angeles, Orange County, and Riverside!