AALL is accredited by MHRA and holds a GMP certificate. The site was last inspected in March 2019. The site is primarily involved with finished formulation testing of licensed medications.

 

AALL is capable of testing solid orals, liquids, ointments, and injectables. Solid orals include tablets, capsules, powders in sachets and powders for oral solution and suspension (PFOS). The Facility is equipped with a range of instruments and equipment to facilitate both physical and chemical testing.

 

The core area testing of the laboratory is related to release testing of products imported from outside the EU.

 

The laboratory has an open plan with office and documentation room.

 

Wet Chemistry, physical and chemical analysis is carried out in the open plan laboratory. The lab is equipped with instruments and equipment such as the hardness tester, Friabilator, Disintegration tester, Karl Fischer moisture analyzer, HPLC (4), and Dissolution testing(2), IR spectrophotometer, Gas Chromatography etc 

 

A separate balance room has been created within the laboratory where all weighing activities are been carried out.

 

The rear end of the laboratory is used for washing of glassware. The fuming hood is close to the washing area.

 

The laboratory is serviced with air conditioning units to ensure all analytical activities are conducted under client recommended conditions and samples are stored under recommended storage conditions.

 

 Alpha Analytical Laboratories Limited is run by a team that has been involved in the testing of finished product formulations over a combined period of 30 years. The Laboratory is supported by a team of 2 from the head office with a combined experience of nearly 20 years between them. 

 

Alpha Analytical Laboratories Limited‘s objective is to exceed the customer expectations by offering consistent quality service through cGMP

 

The following are key components to achieve this:-

 

• Operating within the framework of the formal quality system based on cGMP

• Commitment and team effort by all employees engaged in all aspect of testing.

• Continuous upgrade of equipment, instrument and training of personnel to meet the legal obligations of cGMP

• Continuous inspection / self inspection of the quality system.

 

QA is responsible for the issue, review, approval and retrieval of documentation and manage the quality management system.

 

Standard instructions are laid down in the form of QCP’s for preparation, review, approval and distribution of documents.

 

Examples of key Documentations:

• Product specification.

• General Analytical methods.

• Blank test data sheet.

• Certificate of analysis.

• Analytical reports.