Pharmaceutical and Health Industries are highly regulated with continuously evolving regulations and regulatory expectations. Advancements in technology as well as the communication revolution raised the regulatory challenges and almost unified the requirements across the globe. Compliance to international quality standards and regulatory requirements is a continuous and essential component of this industry. While compliance to Good Manufacturing Practices and being always prepared for regulatory inspections is incorporated in the day-to-day business of these organizations, it is still the biggest challenge for many. Pharmaceutical Quality Management System (PQMS) is a wide-ranging concept that comprises GMP and assures and enables sustainable compliance to regulatory requirements and product quality standards. PQMS is the umbrella of compliance to all Good Practices. Having a comprehensive PQMS guarantees compliance and provides the confidence and assurance to achieve and sustain product quality. Under the wide concept of PQMS , lies all Good Manufacturing , Storage, Distribution,Laboratory , ….practices with all relevant details and requirements.
PQMS covers the life cycle of the industry and the product starting from the idea to the product discontinuation.

Applying PQMS successfully can be the principal factor at achieving:

• • Product Quality.
• • Successfully facing regulatory inspections.
• • Product designed with GXP taken into account.
• • Product and Process knowledge managed through whole life cycle.
• • Product realization achieved.

At Pharada, we possess the knowledge and expertise to design and implement the PQMS that suits your organization if you are a newcomer or evaluate and work with you to upgrade your PQMS if you are already in the market.

Our services and consultations tackle all quality related aspects and PQMS components, including - but not limited to - Good Manufacturing Practices, Good Storage and Distribution Practices, Good Laboratory Practices and Good Clinical Practices.
We can help you in a holistic approach or in more specific problem solving and area improvement approach. In addition to all GMP related requirements such as SOPs preparation, Documentation system setup, and Validation master planning, Pharada supports you to master and control the most challenging areas of PQMS:

• • Quality by Design
• • Quality Risk Management
• • Change Management
• • Deviations Management
• • Corrective Actions and Preventive Actions (CAPA)
• • Supplier Qualification and Audit

Facing Regulatory inspections:

We assist you getting prepared for planned or unplanned regulatory inspections through the above process or a direct simple exercise of performing comprehensive and/or Focused Mock inspection to identify the potential observations and assist you in overcoming them.
We assist you in preparing the site master file and all pre-inspection documentation.
We can lead your back-office during the inspection.
Our experts can also assist your post-inspection to set your CAPA and effectively deploy it.

Our Approach to support you:

Our experts work with you starting from Gap analysis to identify where your organization stands with regards to the requirements and prioritize the gaps based on their criticality and impact, proposing the proper actions and the plan to execute them, and equipping your people with knowledge and resources needed to execute and mentoring them throughout the journey.
We believe in building capacity into your organization and thus all our consultations are based around this concept, we aim to enable the organization to own its quality system and accordingly being able to maintain product quality.