Pharma
- Consulting Services
- GMP (FDA/MHRA/TGA/WHO/COS)
- DMF
- ISO 22716:2007
- Pharmaceutical Products (Who 957:2010)
- Custom Synthesis
- PHARMACEUTICALS VENDER DEVELOPMENT
- PHARMACEUTICAL ENGINEERING
- ECOVADIS & PSCI compliance support
Consulting Services For
- CGMP ( WHO GMP, US FDA, WHO, TGA, MHRA etc.)
- Pharmaceuticals vendor development
- ECOVADIS & PSCI compliance support
- Pharmaceutical engineering
- Management of custom synthesis
- Assist pharmaceutical manufacturers in establishing GMP complying with international standards.
- Assist clients in developing pharmaceutical venders towards outsourcing generics and contract manufacturing.
- Co-ordinate custom synthesis of organic compounds for clinical and other research applications.
1. Cgmp Consulting:
Covering FDA, MHRA, TGA, COS, WHO
a. Manufacturing Facility:
• Assessment of ‘manufacturing facilities' and ‘Quality System' with reference to the expectations of international regulatory agencies like US FDA, MHRA, U.K (formerly MCA), TGA (Australia) etc. and prepare ‘Gap Analysis' report.
• Design reviews of new facilities for the production of APIs and sterile/non-sterile drug products.
• Advising on the refurbishment of manufacturing facilities.
• Advising on the design of utilities (e.g. Air and Water Systems).
b. Review of Quality System Documentation:
Advise on structure and adequacy of following type of quality documents.
• Quality system procedures. • Standard operating procedures. • Specifications and test methods. • Raw data and other record formats.
c. Material Flow Clearance system:
Review manufacturing flow chart and suggest suitable material flow and clearance system throughout the supply chain beginning from raw material supplier upto customer.
Design recording system to provide traceability for future evaluations and investigations.
d. Validation Programs:
• Preparation of ‘Master Validation Programs' and reviewing progress.
• Review Protocols and assist implementation of Validation Programs for following critical activities.
• Analytical methods • Cleaning methods • Key production operations • Qualification of key equipment's • Utilities like water and AHU system • Manufacturing processes
e. Impurity Profiling:
• Advise on identifying potential impurities in the products per ICH requirements • Degradation studies and shelf life determination. • Evaluation of analytical methods for impurity determination
f. GMP Audits:
• Periodic audits to verify compliance to defined systems. • Assist implementing routine GMP inspections and organizing periodic self-audit program. • Assessment of GMP status in preparation for regulatory audits. • Participation in regulatory audits.
- Review drafts of Drug Master Files (CTD format) against ICH requirements.
- Advise on generation and presentation of relevant data.
- Assist preparation of suitable replies to queries from regulatory agencies and customer.
ISO 22716:2007 gives guidelines for the production, control, storage and shipment of cosmetic products.
ISO 22716 is the new guidance for Good Manufacturing Practices (GMP) for the cosmetics manufacturing industry and describes the basic principles of how to apply GMP in a facility that produces finished cosmetic product.
Benefits of ISO 22716
Integrates the typical requirements for product and process quality Good Manufacturing Practices requirements with other Quality guidance, for example as laid down in the prerequisites for ISO 9001;
Allows for easy implementation in organisations of all sizes and levels of complexity
Forms an internationally accepted basis for quality and safety compliance in the cosmetic products supply chain
Fosters legal compliance as adopted by regulators around the world
Controls and reduces cosmetic products hazards and promotes continuous improvement throughout the supply chain
To maintain the original quality of pharmaceutical products, every party active in the distribution chain has to comply with the applicable legislation and regulations. Every activity in the distribution of pharmaceutical products should be carried out according to the principles of GMP, good storage practice (GSP) and good distribution practice (GDP) as applicable.
Good Distribution Practice (GDP) is that part of quality assurance which ensures products are consistently stored, transported and handled under suitable conditions as required by the marketing authorisation (MA) or product specification
These guidelines do not deal with all aspects of the standards for the storage of pharmaceuticals which are covered in the WHO guide to good storage practices for pharmaceuticals
The dispensing to patients is addressed in the WHO good pharmacy practice (GPP) guide
- Identify capable laboratories and co-ordinate following activities towards supplementing drug development activities.
- Synthesis of drug intermediates and API's in gram to kilogram quantities.
- Process development and contract research.
- Pilot plant manufacture.
- Synthesis of speciality organic compounds for research and clinical studies.
- Short list potential contract manufacturers based on clients needs.
- Assessment of vendor's quality system and contract manufacturing capability.
- Assist vendor to implement cGMP systems meeting international standards.
- Monitor quality system of the ‘Vender' through periodic ‘Quality audits' in line with client's expectations.
We had close association with reputed pharmaceutical design engineers in specialised areas to provide turnkey solutions. The design activity includes:
• Consultancy Services for chemicals and Pharmaceuticals Projects with Expertise in setting up Plants for manufacture of Bulk Drugs and Active Pharmaceutical Ingredients complying to US FDA & GMP Standards.
• Safety audits and preparation of safety manuals, Safety Procedures, Fire prevention and fire fighting systems.
• Effluent treatment and disposal systems, Air handling and air purification and ventilation systems Pollution prevention and control systems.
• Design of facilities for API's finished dosage forms (sterile & non-sterile)
• Design and fabrication of Air handling units for different classified areas.
• Design and commissioning of water systems for use in pharmaceutical processes.
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