Quality Management System

QA Incharge & Management Representative (MR) is responsible for maintaining total quality of systems and products as per GMP requirements.

responsibilities

Major Responsibilities Covers

We, has been implemented quality management system since 2007. The quality management system are consist of one unique quality manual, mandatory quality procedures by the standard and standard operating procedures for the manufacturing and allied activities like management review meeting, marketing, purchasing, vendor approval & performance evaluation, training and quality control.

  • Ensure compliance of national and international regulatory GMP requirements and ISO standard’s requirements
  • Ensure availability of approved procedures and specifications for reference.
  • Review Batch processing and testing records, before giving product release.
  • Review and authorize Validation master plan, Protocols and provide support for validations
  • Ensure compliance of Change control procedures.
  • Carry out process controls, including in-process checks / inspections / line clearance.
  • Investigate complaints, deviations, quality incidents and non- conformances.
  • Handling of regulatory inspections at the site.
  • Take actions on product recalls and investigate the reason.
  • Ensure implementation of pest and rodent controls, as per defined schedules.
  • Review product stability reports. Review batch manufacturing records, verify reconciliation of batch inputs, batch yields and finally release the product.
  • Annual Product Quality Review
  • Vendor development and approval
  • Internal audit
  • To review and approval of master validation program, including equipments, processes, facilities, analytical methods etc.
  • To investigate out of specification results or failure investigation related to testing or manufacturing etc.
  • To ensure sampling of raw-materials and packaging materials as per company procedures.
Authorized QA & QC

Validation & QA Team

At ABHYUDAY INDUSTRIES, validation batches are released only after thorough checks by our experienced QA and QC team to ensure compliance with the highest quality standards.

Rajesh Shah

Mr. Rajesh Shah

QA In-charge | 25+ Years Experience

Paresh Patel

Mr. Paresh Patel

QC In-charge | 6+ Years Experience

Batch Release Conditions:
  • Product meets all specifications
  • Manufactured as per defined process
  • No evidence of deviation
  • Complete review of records & reports
  • Stability studies performed
  • Customer approval obtained
Supplier Management

Supplier & Vendor Management

We follow a strict procedure for approval, assessment, and evaluation of vendors. All materials are sourced only from Approved Vendors, ensuring compliance and consistent quality in every stage of production.

Vendor Assessment
Audits
Work Orders
Performance Evaluation

Main Purchases:

  • 🪴 Psyllium Seeds (Unjha, Gujarat)
  • 📦 Packaging Materials (jute bags, paper bags, HDPE, fiber drums, FIBC)
  • 🔧 Machinery & Equipment
  • 🛡️ Personal Protective Equipment (PPE)

Subcontracted Services:

Pest Management
Laboratory Testing
Steam Sterilization / ETO
Calibration Services
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