Good manufacturing practice. Continuous controls. Premium products.

GMP. FDA-inspected. End-to-end quality.

Quality assurance at Central Glass

For us, quality is more than “compliance”. That’s why we live our quality mission statement, day in, day out, in everything we do, of which our customers and our continuous pursuit of improvement are the focus.

Our experienced quality assurance team ensures strong interfaces between the different functions (process development, production, engineering, quality control, sales and external partners).

We practice the individual components of a modern quality management system holistically, and constantly seek to improve and update these.

In our work with our customers, we listen to their individual needs. Based on our sound quality system we create a continuous quality-to-quality connection between the respective quality systems. This serves for an efficient, goal-oriented and successful long-term cooperation for both partners.

Since the company was first founded, we have been regularly inspected by the FDA and are a certified API manufacturer with an EU GMP certificate in accordance with Art. 111 (5) of directive 2001/83/EG.

Validation activities

  • Development and validation of analytical methods in accordance with current ICH guidelines
  • Process validation/qualification, taking into account the product life cycle
  • Continuous process verification

Central Glass good manufacturing practice – Your benefits:

  • GMP-certified quality management system
  • Robust manufacturing processes based on standardization and meaningful control strategies
  • Products with consistently high quality
  • Support with GMP-related questions
  • Support with legally required documentation

We aspire to truly contribute to society with the environment, safety and quality as our fundamentals. We always place customer satisfaction first and provide products and services that customers love and can use with peace of mind throughout the entire product lifecycle, from product development to disposal after use. We strive to create value for society in harmony with our environment, based on the highest safety and quality standards. We always put customer satisfaction first and deliver products and services that help our customers to be successful and can be used throughout the product life cycle without a problem.

Guidelines for action

  1. We always put our customers first: We always listen to our customers’ concerns and respond immediately.
  2. Our basic approach is to build quality into processes and we strive for the continuous improvement of quality.
  3. We always provide our customers with comprehensive and accurate information about all quality issues.

Start: Identification of validation project

Preliminary evaluation:

  • Assessment of validation needs and prerequisites
  • Assessment of impact on quality/compliance and business
Assessment whether change control is necessary
Scheduling of process validation
Definition and documentation of the validation strategy

Proposal for process validation

Preparation of a quality risk analysis
Lab investigation to define the quality critical parameters and ranges thereof 
Preparation and approval of validation protocol*
Validation performance*
Preparation and approval of validation report*
Validation summary report
End: Completion of validation project

  *Lead management by Central Glass Germany

Get to know Central Glass

Supporting your business: We give 100% to your project. Find out more about our company.



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Our promise

We are the ideal partner for reliability, quality and transparency. At Central Glass Germany, the customer and their individual needs are at the center of our activities.



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Our equipment for tailor-made solutions

With our R&D laboratories and highly flexible cGMP multi-purpose plant, we produce both smaller quantities for early-phase projects, as well as large quantities for commercial uses.



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