Services - Alaiz Pharma Consultancy
At Alaiz Pharma Consultancy (APC), we provide specialized quality assurance and compliance services tailored to the pharmaceutical industry. Our expertise ensures your operations meet the highest standards of quality, safety, and regulatory compliance. With a commitment to precision and excellence, we support our clients in navigating complex regulatory landscapes, streamlining processes, and achieving operational success. Our services are designed to align with the soft, calming hues of trust and reliability, reflecting the APC initials in our dedication to Accuracy, Professionalism, and Compliance.
Our Services
Batch Review & Release
We ensure meticulous control and review of batch documentation across SAP, Manufacturing Execution Systems (MES), and paper-based platforms. Our rigorous process verifies compliance with regulatory requirements and internal specifications, enabling seamless batch release while minimizing risks and ensuring product safety.
Deviation Management
Our robust deviation management approach focuses on thorough root cause analysis to identify underlying issues. We design and implement Corrective and Preventive Actions (CAPA), providing ongoing follow-up to prevent recurrence. Our methods align with global regulatory expectations, ensuring sustainable quality improvements.
QMS Remediation
We specialize in the classification and correction of Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP) deviations. Our Quality Management System (QMS) remediation services enhance compliance by addressing gaps, optimizing processes, and strengthening your quality framework to meet international standards.
Audit Support
We prepare your organization for successful audits by regulatory bodies such as the Dutch Health and Youth Care Inspectorate (IGJ), the European Medicines Agency (EMA), and internal reviews. From gap assessments to mock audits and corrective action planning, we ensure readiness and compliance.
Document Control
We create, revise, and manage Standard Operating Procedures (SOPs), Work Instructions (WIs), and QMS forms to ensure clarity, compliance, and operational efficiency. Our document control services maintain consistency and traceability, supporting your quality systems with precision.
GDP Support Activities
GDP – Support Activities (Certified, Not Yet Registered as Responsible Person)
Completed GDP training including RP responsibilities; currently supporting GDP activities under supervision.
Responsibilities include:
- Applying knowledge of GDP regulations and RP responsibilities in daily QA support tasks
- Supporting the implementation of GDP-compliant processes in collaboration with the QA team
- Assisting with the qualification of customers and suppliers, including documentation review and follow-up
- Handling documents related to deviations, CAPA, and change control processes
- Supporting maintenance of the GDP Quality Management System
- Participating in the review and update of procedures related to licensing and compliance
- Assisting with the traceability and status management of medicinal products
- Gaining practical experience in areas such as complaints handling, recalls, and document control
- Supporting cold-chain documentation and ensuring data is complete and compliant
- Contributing to document creation and maintenance in Veeva QualityDocs
- Working closely with the RP and QA team to strengthen understanding of EU GDP Guideline 2013/C 343/01 and related regulations