Services - Technical

TURNKEY PHARMACEUTICAL PROJECTS – Pharmaceutical Formulation units

We are specialized in setting up of Pharmaceutical Formulation Plants from Concept to Commissioning. This includes Preparation of Factory Layouts, Architecture and structural designing, designing of HVAC (AHU) system, Water system & other Utilities, BMS, Identification and Installation of Machineries and Equipment etc. The entire requirements to setup a Pharmaceutical Formulation facility shall be done by us, including regulatory and legal requirements, in setting up and commissioning a new facility.

We offer turnkey projects for pharmaceuticals as per WHO-GMP, PIC/S, USFDA, MHRA, TGA and EU-GMP norms and requirements. We offer cost effective solutions to set up pharmaceutical projects for start-ups and assist in identifying products for different markets, worldwide, and formulation of selected molecules based on requirements of the markets. We ensure that the staff deployed in the new facility is trained in all aspects of GMP before they take up their assignment in the new facility.

FACILITY ACCREDITATION WITH REGULATORY AGENCIES (USFDA, PIC/S, MHRA, EU-GMP etc.)

We shall develop Quality Management System for new facilities to get the facility accredited with various regulatory agencies (USFDA, MHRA, EU-GMP, PIC/S etc). The entire requirements for the regulatory accreditation shall be provided, which include developing a robust documentation system, Validation, Calibration, mock audits, training etc.

UPGRADATION OF EXISTING FACILITY TO MEET WITH THE REGULATORY REQUIREMENTS OF REGULATED MARKETS

We shall assist in developing a Quality Management System for Scheduled M complied facilities to meet with the Quality System requirements of Regulated markets and thereby accrediting the facility with USFDA, MHRA, EU-GMP, PIC/S etc. The solution involves up-grading documentation and changes in the design of the facility, if required. We shall train the technical personnel on all aspects of regulatory requirements of regulated markets.

GMP TRAINING FOR PHARMACEUTICAL MANUFACTURERS

We shall provide technical training on GMP, GLP etc. for your technical personnel to keep them updated with their technical knowledge and recent trends in the industry for efficient operation of the facility without any rejections or recalls. The training includes preparation of the facility for plant audit and how to face the audit by the Customers and Regulators.

BOTTLENECK ANALYSIS AND THROUGHPUT SOLUTION FOR PHARMACEUTICAL MANUFACTURERS – PRODUCTIVITY ENHANCEMENT

The ‘Operations’ experts of our Consultancy services shall conduct Bottleneck Analysis of your production lines and suggest suitable throughput solution for the effective utilization of production lines and thereby saving the cost in operations of the unit. Performance measurement of the company, divisional performance measurers and performance management etc shall be carried out by the experts in the field for the effective operation of the facility producing pharmaceutical formulations.

PLANT AUDITS AND TECHNICAL INSPECTIONS

The auditors of our Consultancy services shall conduct periodic facility audits and inspections to ensure that the facility is complied with the requirements of cGMP and systems are in place with respect to the Quality Management System (QMS) of the organization. The gaps will be identified and detailed report shall be submitted together with the proposed action plan to comply with the non-conformities identified during audit/inspections.

DEVELOPING AND IMPLEMENTATION OF QUALITY MANAGEMENT SYSTEM (QMS) FOR PHARMACEUTICAL MANUFACTURERS

We can develop a Quality Management System (QMS) for your organization complying to regulatory requirements of the Regulated markets and thereby ensuring that a proper system is in place for the entire operations of the facility. The QMS will be implemented under the following headings;

MANAGEMENT
PERSONNEL
DOCUMENTATION & DATA
FACILITIES
MATERIALS AND PRODUCT CONTROL
PROCESS ASSURANCE
QUALITY CONTROL
INCIDENT MANAGEMENT