Site Licensing and Good Manufacturing Practices (cGMPs)
Herbal Consultants Pvt. Ltd. has its expertise in setting up manufacturing units starting right from the beginning of selecting appropriate location and land, layout blueprints, turnkey projects, clean room set-up’s, machinery selection and installation, process set-up and validation until the commercial production. We build the facilities according to the USFDA-GMP, WHO-GMP and any other country specific GMP standards.
All companies who manufacture, package, label or export a natural or dietary product for sale must have a Site and Product License that has been issued by the FDA or FSSAI. Our services in this area include:
- Territory and land selection for setting the manufacturing unit.
- Layout and blueprints development with approval from respective regulatory authority.
- Structural development.
- Turn-key and clean rooms project management.
- Machinery identification, selection and finalization.
- Setting up innovative and cost reducing manufacturing operations.
- Guidance in GMP certification, Manufacturing licenses, Halal, Kosher, NSF and ISO certifications.
- Development and implementation of a GMP compliant quality system.
- GMP audits.
- Preparation of Quality Assurance Reports.
- Preparation of Site License application dossiers.
- Site License Renewal applications.
- Site License annexations and amendments.
- Responding to government Information Request Notices (IRNs).
- Guidance in contract and customized manufacturing.
To ensure herbal dietary supplement cGMP compliance, FDA performs on site inspections and audits. Any facility directly impacted by law is encouraged to prepare in advance for an FDA inspection as the FDA does not give prior notice before showing up for an inspection.
cGMP regulations state that a quality control personnel must ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record. We can help fulfill this vital requirement/role on your behalf.
To help meet your cGMP requirements, our services in this area include:
- cGMP audits and training on Indian GMP, Drug and Cosmetics Act (DCA), FSSAI, USFDA 21CFR part 111 subparts A-P, MHRA, Eu-GMP, etc.
- Quality assurance person training.
- Drafting Standard Operating Procedures and Revision.
- Quality assurance for the assessment and release of finished products for sale.
- Developing Dietary Supplement stability protocols.
- Preparation and review of Finished Product Specifications, Master Manufacturing Records and Batch Records.
- Investigation of complaints and non-conformances.
- Label review and control.
- FDA Establishment Inspection Reports.
- Responses to FDA Warning Letters and inspectional observations.
- Develop lab and vendor/supplier qualification systems.
Whether you are a manufacturer, packager, labeler, exporter or importer; whether you are just beginning or simply need experts to guide you through the process, our quality and compliance specialists can help you and make the process very easy.