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GMP SERVICES

We offer many GMP services which can help the clients across globe, ranging from audits to various consulting services. We provide comprehensive, hands-on GMP Quality Compliance services to the pharmaceutical industry ranging from audits to various consulting services.

GMP AUDITS

We frequently perform GMP audits at a various supplier sites across the globe to ensure GMP compliance.

  • We carry out various audits including full Site audits which focus on the facility’s quality management systems and cover a large number of products.

  • The GMP audits are conducted by our qualified and experienced auditors at no charge to the supplier, every 3 years. With permission of the supplier, we add the audit report to our report library.  

  • By purchasing our GMP audit reports from library, our clients only spend a small fraction of the costs usually associated with conducting a supplier audit.

  • Our commissioned audits and audit partnership services can minimize the cost of the audit and ensure that our clients receive personalized reports with areas most relevant to their operations.

  • With this huge experience, you can rely on us to take complex compliance issues to conclusion.

Vendor Qualification

The process of approving the finished dosage form manufacturer for an API to be used for specific product and includes following.

  • Vendor Capacity, Vendor Location, Vendor Certification
  • Considers the manufacturers either new (qualification) or existing (re-qualification)
  • Evaluation of vendor reputation, vendor’s operation and quality of each manufacturing process
  • Selling prices
  • Technical evaluation, Technical dossier from API manufacturer
  • Test product sample checking and checking of finished dosage form of that API

Site Audits

We cover GAP analysis, Inspection Readiness and For-Cause Investigation under Site Audits.
GAP Analysis (QMS)

This is GMP compliance audit, often referred to as ‘GMP Mock Audit’ or ‘GMP Gap Analysis’. with many years of experience we are able to provide support in all the following topics.  

  • Raw materials, excipients, active ingredients
  • Finished pharmaceutical products (e.g. solid dosage forms, sterile products)
  • Pharmaceutical, chemical and/or biotechnology production processes
  • Production, quality control, warehousing, logistics and IT
  • Integrated quality assurance systems
Inspection readiness

This is ‘Pre-regulatory Inspection audit’. An audit conducted by someone external to the organization with the purpose of discovering GMP deficiencies and includes following.  

  • Preparedness evaluation for regulatory inspections
  • Readiness assessment of site personnel for Pre-approval inspections by USFDA or other regulatory agencies
  • Training the personnel for inspector interviews
  • Comparing Chemistry, Manufacturing and Control (CMC) submissions against supportive documentation
  • Technology transfer assessment for manufacturing and test methods
For-cause investigation

The Code of Federal Regulations (21 CFR 820) expects the drug manufacturers to conduct an immediate failure investigation when the product is reported in OOS category. Pharmazone can help in following manner.   

  • Our consultants are capable to investigate the probable reasons like, laboratory error, non-process related error, process related error.
  • We review analysis and related data. Our expert also works with the analyst to conduct an investigation.
  • We ensure the reliability of quality assurance department with described SOP for the area or the process where the incident occurred.

Computer system validation

Before any computer system is used at site, an appropriate level of validation should be in place to demonstrate that the systems are fit for the use and that the computer system produces reliable data.

It is a responsibility of the system owner to ensure that any computer system used during the process complies with the relevant policies/procedures. Following are the Capabilities. Following are the Capabilities.

 

  • Conducting CSV audits of the software, infrastructure and IT services at your premises or off-site.

  • Comprehensive audit with focus on a particular functional area, business operation, or computer system.

  • Compliance verification with 21 CFR Part 11 and other FDA regulations, Good Automated Manufacturing Practice (GAMP), ICH guidance.

  • Assessing other quality system elements and supporting processes including staff training, SOPs, document control, corrective and preventative actions, record retention, and problem reporting.

  • Our comprehensive CSV services cover one or more of following.

    1. User Requirement Specification

    2. System Validation (Development Life Cycle) activities and documentation

    3. Regulatory Compliance

    4. Configuration management

    5. Installation and maintenance

    6. Change Control

    7. Physical and electronic security

    8. Backup and recovery

GMP Monitoring

audit

In general, GMP monitoring (on-site monitoring of manufacturing process) depends on manufacturing process time period and expectations i.e. only monitoring of critical processes. Following activities shall be monitored at manufacturer site:

  • Dispensing of raw materials, Packaging Material and Review of Analytical data of all Raw Materials
  • Monitoring of Production activities for manufacturing of various formulations.
  • Ensure that batches shall be executed as per the Batch records/SOP.
  • Review of all investigations, Deviations and Change controls pertaining to the batch/batches
  • Ensure that all manufacturing and analytical equipment used in batch manufacturing are adequately qualified, Calibrated and in the good state of Maintenance.
  • Review of electronic data, Audit trail records of analytical equipment, working standards qualification records.
  • Review of Training records of involved personnel, Microbiology laboratory records, Environment monitoring records of manufacturing days, water analysis data used in the process and trend data.

Quality Consulting

With extensive experience of our experts, pharmazone can contribute to Quality consulting and upgradation of any manufacturing sites. We can offer as following:  

  • Quality Systems components assessment, such as internal SOPs, specifications, change control, trend analysis, input inspection, outsourced operations control, and personnel development
  • CAPA programs assessment

Audits Reports

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Products

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