Siddhi RAC Services provides:

• Assistance and provision of solutions to allow your company to maintain and comply with cGMP requirements.
• Contract Release for Supply of Therapeutic and Animal Health products.
• Assistance in setting up systems and processes for Herbal Medicines.
• Remediation services to Regulatory citations, cGMP and technical non-compliances.
• Technical support in the front or back office during actual, pre- and post-GMP audits by your Corporate, TGA, APVMA, ACVM, other regulatory auditors and Contract Giver auditors.
• GMP audits in APIs, pharmaceuticals, complementary products, consumer goods, medical and therapeutic devices, veterinary products, sterile and non-sterile products.
• Assistance in achieving compliance to your GMP audit observations from your Internal, Third Party manufacturer or Supplier and Pre-contract audits.
• Assistance in preparation, updating and upgrading your factory Quality systems and processes.
• Technical and GMP training and facilitating your training requirements which can be tailored to suit and meet your requirements.
• Assistance in updating and upgrading your documentation requirements for your SOPs, Quality Manual, Site Master File, manufacturing batch documents, Validation Master Plan, Product Quality Review, etc. See our Products and Templates page for further details.
• Temporary filling-in key positions and relieving the pressure of time and GMP compliance while you seek the right person.
• Assistance in GMP building requirements.
• Project management.
• Assistance in QC and QA requirements.
• Assistance in GLP requirements.
• Assistance in setting up or reviewing product stability studies programme.
• Warehousing requirements and temperature sensitive shipping requirements.
• Assistance with new product introduction.
• GAP Analysis In All Technical Departments And Remediation Plan To Overcome The Deficiencies Observed During GAP Analysis
• Review Of Analytical Data (Hard Copies And Electronic Data Review)
• Review Of OOS, OOT, Analytical Incidents
• Review Of QMS (Deviations, Change Control, Complaints, Recalls, Incidences)
• Data Integrity Assessment Through Exhaustive Protocols
• Set Up Of New QC Laboratory Or Upgrading Existing QC Laboratory

Technical assistance for manufacturing involving:

• Therapeutics, OTC, Complementary, Devices, Veterinary, Food or Cosmetic manufacturing and packaging.
• API, Solid dose, Creams & Liquids, Aerosol manufacturing and packaging.
• Sterile and Non-sterile product manufacturing and packaging.

We provide solutions to:

• Resolve GMP problems and issues.
• Ensure GMP compliance.
• Outsource GMP auditing and certain GMP functions.
• GMP building compliance by providing GMP compliance criteria for new or converted factories.

Siddhi RAC Services provides:

• Dependability, with solid, extensive and broad experience.
• GMP systems and processes.
• A Start up specialist who can immediately make a difference.