Qualification & Validation Services

Microstar is a privately owned company formed in 1991 to provide services to the Healthcare industry. The business is dedicated to the Pharmaceutical and Biopharmaceutical industry specialising in Qualification and Validation covering facilities, utilities, plus processing and packaging equipment.

The company have managed, Engineered and Validated projects for major Pharmaceutical clients from conceptual design to project hand over in the following areas of Pharmaceutical manufacture.

• Oral Liquids
• Solid dosage (Tablets & Capsules)
• Topical (Creams & ointments)
• Parenterals (aseptic sterile manufacture)
• Metered Dose Inhalers (MDI's)
• Packaging (All dose forms)
• Active Pharmaceutical Ingredients (API's)
• Biopharmaceuticals

Microstar are able to offer clients the following services:

• Preparation of User Requirement Specifications (URS).
• Management of the design and development process to current standards.
• Prepare any / all of the key documentation to support the project.
• Benchmark suppliers to support the selection process.
• Provide Company GMP and software audits.
• Pre-Delivery acceptance testing on behalf of our client.
• On site Testing and commisioning.
• Equipment Qualification (DQ / IQ / OQ / PQ).
• Computer / Control System Validation.
• Cleaning Validation.
• Process Validation.
• Training and Production support.