In addition to pharmaceutical GMP, Taj Pharma maintains an ISO 9001:2015 certified Quality Management System (QMS) covering site operations. ISO 9001 provides the organisational management-systems layer that complements the product-focused GMP framework.
What ISO 9001 Adds #
- Process approach to managing the business - inputs, outputs, interactions explicitly defined
- Risk-based thinking embedded across organisational decisions
- Leadership and strategic-direction alignment with quality objectives
- Measurable performance indicators (KPIs) with periodic management review
- Customer focus - requirements captured, satisfaction measured
- Continual improvement culture supported through CAPA and internal audit
Scope of Certification #
Taj Pharma's ISO 9001:2015 certification covers design, development, manufacturing, packaging and distribution of pharmaceutical products from our Sarigam facility. The certificate is issued by an accredited certification body and renewed through annual surveillance audits and three-yearly re-certification.
Integration with Pharmaceutical Quality System #
The ISO 9001 QMS is integrated with the ICH Q10 Pharmaceutical Quality System - they operate as one system with a single set of SOPs, documents and records. This integrated design prevents duplication while ensuring both pharmaceutical-specific GMP requirements and broader organisational quality objectives are met.
Key ISO 9001 Clauses in Action #
| Clause | How It Applies |
|---|---|
| Clause 4 - Context of the Organisation | External and internal issues mapped; interested parties identified (regulators, customers, suppliers, employees) |
| Clause 5 - Leadership | Quality Policy signed by senior management; roles, responsibilities and authorities documented |
| Clause 6 - Planning | Risks/opportunities assessed; quality objectives cascaded to each function |
| Clause 7 - Support | Competence, training, infrastructure, documented information controls |
| Clause 8 - Operation | Product realisation from customer requirements through delivery |
| Clause 9 - Performance Evaluation | Customer satisfaction, internal audit, management review |
| Clause 10 - Improvement | Non-conformity, corrective action, continual improvement |
Customer-Facing Benefit #
For distributors and tender customers, ISO 9001 certification provides an independent attestation that Taj Pharma operates against a recognised management-systems standard - complementing product-specific GMP certification and simplifying supplier-qualification assessment.