Manufacturing

Manufacturing Standards & Best Practices

Prikind follows rigorous manufacturing standards to ensure product quality, patient safety and regulatory compliance. Below is a concise overview of the systems, processes and controls we maintain across our facilities.

Good Manufacturing Practices (GMP)

All production is performed in WHO-GMP aligned clean areas with defined personnel flows, controlled access, and environmental monitoring. Key GMP controls include:

  • Segregated zones for raw materials, in-process, and finished goods
  • Defined gowning and personnel hygiene protocols
  • Validated cleaning procedures and cleaning logs
  • Environmental monitoring (air particulates, viable counts, surface monitoring)

Quality Management System (QMS)

Prikind operates a documented QMS covering SOPs, batch records, change control, CAPA and internal audits. Highlights:

  • SOP library for all critical manufacturing, QA and QC activities
  • Electronic / paper batch records with signatures and audit trails
  • Change control process for formulation/equipment/process changes
  • CAPA system to track non-conformances and preventive actions

Process Validation & Equipment Qualification

Every critical process is validated and equipment is qualified as per protocol (IQ/OQ/PQ).

  • IQ – Installation Qualification: verify correct installation
  • OQ – Operational Qualification: confirm equipment functions within limits
  • PQ – Performance Qualification: demonstrate consistent production at scale
  • Periodic re-qualification schedule and preventive maintenance logs

In-Process Controls (IPCs)

IPCs are defined at critical stages to ensure batch integrity and yield.

  • Raw material identity & weight checks (material reconciliation)
  • Granulation, compression, coating, filling, and packaging checkpoints
  • Real-time monitoring for critical parameters (torque, humidity, blend uniformity)
  • Hold-time controls and quarantine procedures for suspect batches

Environmental Controls & Waste Management

We manage effluent, solvent and solid waste responsibly with focus on recovery and reduction.

  • Effluent treatment and solvent recovery units for reuse where safe
  • Segregation and disposal of hazardous vs non-hazardous waste
  • Emissions monitoring and adherence to local environmental norms
  • Periodic environmental audits and sustainability KPIs

Health, Safety & Personnel Training

Employee safety and competence are ensured by training programs and safety systems.

  • Induction & annual GMP training for all production & QA staff
  • Job-specific qualifications (operating procedures, QA sampling)
  • Personal Protective Equipment (PPE) and safety drills
  • Incident reporting, investigation and corrective actions

Documentation & Traceability

End-to-end traceability from raw material lots to finished product batches is maintained.

  • Raw material certificates of analysis (COA) and vendor approval records
  • Batch records with material reconciliation and retention sample policy
  • Ability to trace SKU → batch → vendor → QC results for recalls or investigations
  • Document retention policies aligned with regulatory requirements

Quality Control (QC) Lab

Our QC lab performs identity, potency, purity and stability testing using validated methods.

  • Analytical methods: HPLC, GC, UV-Vis, dissolution apparatus, microbial testing
  • Stability chambers for ICH conditions (long-term & accelerated)
  • Reference standard management and calibration of instruments
  • Release testing & Certificate of Analysis (COA) issuance per batch

Supply Chain & Vendor Management

We qualify vendors, enforce incoming QC, and monitor supplier performance.

  • Vendor qualification and annual performance reviews
  • Raw material sampling and COA verification on receipt
  • Approved vendor list (AVL) and alternate sourcing plans
  • Inventory controls to avoid stock rotation issues and expiries

Packaging & Cold Chain

Packaging is selected to protect product integrity; cold chain maintained for temperature-sensitive SKUs.

  • Child-resistant and tamper-evident packaging options
  • Barrier films, desiccants and UV-shielded bottles for sensitive actives
  • Validated cold-chain logistics for refrigerated products (2–8°C)
  • Packaging integrity checks and label accuracy verification

Audits & Regulatory Readiness

We schedule internal audits, welcome third-party audits, and maintain regulatory dossiers for quick response.

  • Internal GMP audits and management review cycles
  • Third-party audits for certification renewals and customer audits
  • Regulatory dossier maintenance for CDSCO and export requirements
  • Mock recall drills and traceability testing

Continuous Improvement & Metrics

We track operational and quality KPIs to drive improvements.

  • Batch yield (%) and cost-per-batch
  • Non-conformance rate and CAPA closure times
  • On-time delivery and order fill-rate
  • Shelf-loss / write-off rates and stability failure rates

Retention Samples & Recall Management

Retention samples and a documented recall process ensure fast, traceable action if issues occur.

  • Retention sample policy (per SKU / per batch, stored under controlled conditions)
  • Recall SOP with roles, communication templates and trace-back procedures
  • Regulatory notification process and customer communication plan

Private Label & Contract Manufacturing Controls

Dedicated controls for co-manufacturing and private label to maintain segregation and confidentiality.

  • Contract manufacturer agreements and technical transfer protocols
  • Confidentiality & IP protection during co-development
  • Separate labeling and batch coding for private label runs
  • Quality checks and agreed acceptance criteria before release

Need detailed manufacturing SOPs or an audit pack?

Request a full audit pack, batch-specific COAs, or a site visit. We support partner audits and documentation transfers for compliance checks.