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Pharmaceutical Quality Control Testing

Pharmaceutical Quality Control Testing & Analysis Services

Lucideon's pharmaceutical quality control testing and validation laboratories are fitted with state-of-the-art analytical equipment and testing facilities.

Our team of highly qualified and experienced technical staff will work with you to develop and deliver testing and analytical solutions to add value to your product or project.

With analytical and method development capabilities supporting our quality control facilities, you can minimise disruption, transit times, and costs with a provider you can trust. This is what sets us apart from other test houses - we don't just provide the numbers, pass or fail. We'll work to understand the results, and if they do not meet your quality criteria, we’ll help with troubleshooting to ensure they will.

Pharmaceutical Quality Control Testing

 

Stability storage testing

Stability of pharmaceuticals in storage is extremely important for maintaining their functionality. At Lucideon, we test your products for storage in a range of humidity and temperature conditions. We perform accelerated ageing to simulate how your products will perform over an extended period, so you get your results quickly and go to market with confidence.

Our experienced staff aid with study design, planning, and management of stability storage testing, including stability storage methods, retest intervals, and shelf lives.

Capabilities

  • testing to cGMP
  • testing for schedule I-V controlled drugs
  • temperature and humidity testing
  • testing for climatic zones I-IV
  • analytical support capabilities, e.g. testing for leachables

ICH guideline compliance

Our stability storage walk-in chambers are monitored 24/7/365 and have built-in safeguards to give you peace of mind. Additional stand-alone cabinets enable us to offer alternative parameters including refrigerated, frozen, and client-defined storage conditions.

The standard ICH conditions are:

  • 25°C/60%RH - real time storage condition
  • 30°C/65%RH - intermediate storage condition
  • 40°C/75%RH - accelerated storage condition

 

Accreditation

In the UK, Lucideon is a UKAS-accredited testing laboratory (No. 0013) and our pharmaceutical/GMP laboratories hold an MHRA certificate of GMP compliance (No. UK GMP 43644 Insp GMP/IMP 43644/34927202-0002, dated 29/02/2024) for contract QC resting of human and veterinary medicines. The Lucideon pharmaceutical/GMP laboratories also hold a current FDA certificate of registration and were successfully inspected by FDA in September 2019.

In the US, Lucideon is Nadcap-accredited and has 10 CFR 50 Appendix B Quality Assurance accreditation.

Product validation

Our complete product validation service is supported by a wide range of analytical capabilities, including advanced surface analysis and expert knowledge. Lucideon offers you:

  • patent infringement support - providing independent analysis
  • cleaning validation – ensure your product meets the strict cleanliness requirements using our cleaning validation service, VALIDATA
  • counterfeit drug detection – quick and effective detection using surface analysis techniques

We are also licensed to handle restricted products. Further details can be provided if required.

Further information regarding our complete testing suite can be found on our microbiology and chemistry pages.

 

See our pharmaceutical services video:

White Papers

Protecting Products and Patients in Today's Prescription Drug Abuse Epidemic

In this white paper, we discuss the journey behind Lucideon's proprietary iCRT-deter technology

Single Use Systems
Single Use Systems in the Pharmaceutical Industry - Advantages and Considerations

In this white paper we discuss some of the testing and validation considerations that pharmaceutical manufacturers should look at when implementing single use systems

Quality by Design for the Pharmaceutical Industry

The concept of Quality by Design (QbD) is not a new idea but it is only in recent years that it has been considered for all aspects of the development process for pharmaceutical products

Pharmaceuticals
Abuse Deterrence for the Pharmaceutical Market

This white paper explores the market drivers for abuse deterrence and identifies possible solutions

Tablets
Surface Analysis Exposes Counterfeit Medicines

Surface Analysis is assisting the pharmaceutical industry in a number of ways, including counterfeit detection

Balance
Drying Processes - the Balance Between Efficiency and Product Quality

Drying is an important process in almost all industry sectors, including ceramics, pharmaceutical, food, chemical, construction and semiconductors

Case Studies

Lucideon Supports Wockhardt to Get the COVID-19 Vaccine to Market

Testing carried out at Lucideon's GMP testing laboratories and analytical chemistry facilities

Tablets
Surface Yellowing of a Drug Tablet upon Light Exposure

ToF-SIMS investigation into tablet discolouration

Crystallite Contamination
Crystallite Contamination in a Drug Formulation

Analysis by time-of-flight secondary ion mass spectrometry

Lucideon Supports Environmental Monitoring Qualification of GMP Laboratories

Environmental monitoring qualification of new facilities

Mouthwash
Visualisation of Oral Microbes in Mouth Care Rinses

Lucideon visually demonstrated the effects of mouthwash treatment

Cleaning Product
Lucideon Validates the Efficacy of Sterilising Products

Validation of the effectiveness of detergents, cleaning wipes and spray and wipe products in removing surface bacteria