Good Manufacturing Practices (GMP)
 

1.   Development and implementation of plans and architectural layouts for new facilities. Reviews and upgrades of existing facilities to ensure cGMP requirements are met with regards to:

-         Building layouts, internal construction and surface finishes

-         Proper materials flow and personnel movement

-         Proper warehouse practices (product and materials storage)

-         Water Systems

-         HVAC Systems

-         Equipment installation washing and storage

-         Sterilization Systems

2.   Authoring of GMP documents as dictated by clients requirements such as manufacturing and packaging records, standard operating procedures (SOPs), quality control specifications and test methods, validation protocols.

3.   Compliance assessments based on FDA regulatory standards covering the manufacturing of :

-         Tablets, capsules, semi solids, external and internal non-sterile formulations

-         Sterile formulations

-         Active Pharmaceutical Ingredients (API’s)

-         Biotechnology formulations

4.   Conducting mock GMP audits, prior to regulatory authority audits, to access the level of GMP compliance

5.   Participation in GMP audits by regulatory agencies and post audit follow-ups to aide the client in preparation of a response to any issued audit reports

6.    Development of maintenance and equipment calibration programs

7.    GMP training

Validation and Qualifications:

        Covering various aspects of pharmaceutical process validations  and preparing:

-         Validation Master Plans

-         Validation Protocols (covering DQ, IQ,OQ, PQ)

-         Validation reports and reviews of  data

-         Analytical method validation protocols

-         Analytical method validation reports and reviews of data

Quality Management:

o Quality Control sampling and testing program reviews to maximize the use of resources at hand

o Development of analytical equipment calibration programs

o Analytical method validation

o Reviews and implementation of  Good Laboratory Practices (GLP)

o Preparation of laboratory documentation such as:

- Standard Operating Procedures

- Specifications

- Test methods

- Sampling plans

o Microbiological testing programs such as:

-         Media preparation and testing

-         Culture preparation and maintenance

-         Demineralised water, potable water and water for injection (WFI)

-         Environmental monitoring

-         Sterility testing

Regulatory Agency Documentation:

 Preparing documents such as:

-         Audit report responses and follow up activities

-         Drug Master Files (DMF) for FDA submissions

Product Development Services (PDS):

     Product Development Services with expertise in development of:

-         Solid Dosage Forms

-         Liquid Dosage Forms

-         Trans Dermal Delivery Systems

-         Small Molecules

-         Proteins and Peptides

-         Lyophilized formulations