Pharmaceutical Quality Assurance is established through Good Manufacturing Practices (GMP). GMP provides a structured framework to ensure that all pharmaceutical products are manufactured reliably so that each product meets its specifications based on quality standards.
The GMP requirements reduce the potential for contamination, product mix-ups, deviation from the standard manufacturing process and final product defects that cannot be identified through testing at the end of the manufacturing process. This means that Quality must be a consideration at every step of the manufacturing process - from receipt of raw materials to distribution of finished product.
Every manufacturer across the globe must comply with the GMP guidelines established by the US FDA (21 CFR Parts 210 & 211), European Medicines Agency (EMA – EU-GMP), World Health Organization (WHO), and the Central Drugs Standard Control Organisation (CDSCO - Schedule M, India).
This article outlines and describes the essential principles of GMP, as well as their importance and relationship to each other and the assurance of quality in the final product.
1.1 Quality Policy and Objectives: A quality policy of company establishes a commitment to the safety of its patients and the quality of its products. Quality objectives should be quantifiable and regularly reviewed.
1.2 Quality Manual: It describes the organizational structure, responsibilities and how documents are routed through the system in order to monitor compliance with the quality policies and objectives.
1.3 Deviation, Change Control and CAPA: All deviations must be investigated to determine their root cause and follow-up actions must be taken to prevent their recurrence.
1.4 Management Review: Periodic senior management reviews must assess the quality of the organization using statistical measures such as deviations, complaints, and audit results.
A strong QMS eliminates the need for decisions based solely on conjecture or assumptions and guarantees regulatory compliance throughout the entire product lifecycle.
2.1 Organizational Structure: There should be clear responsibilities between quality assurance, quality control department, production department, engineering department and the storage areas of the organization.
2.2 Competence & Training: Individuals must complete initial and on-going training based upon their job responsibilities and their duties when working in a GMP facility.
2.3 Hygiene & Health: All employees must be medically fit and healthy and must wear protective clothing and follow proper personal hygiene procedures.
2.4 Access Control: Access to all areas of the facility, including sterile areas and manufacturing areas, must be limited to authorized personnel only.
2.5 Culture of Quality: Employees must have a culture of quality where they are encouraged to report any discrepancies in the GMP processes and provide suggestions for improvement without any fear.
All personnel who are properly trained and motivated are the foundation of the GMP compliance program.
3.1 Logical Flow: The flow of personnel, material, and finished product must be separated from one another to prevent cross-contamination.
3.2 Separation of Areas by Operation: Dedicated areas should be established for the following operations: Dispensing, Granulation, Compression, Coating, and Finishing.
3.3 Classification of Cleanrooms: Facilities must be classified in accordance with either ISO 14644 or EU-GMP (Grades A through D).
3.4 Air Handling Systems: HVAC systems should capable to maintain necessary differential pressures & temperatures between cleanrooms to prevent cross-contamination.
3.5 Surfaces: Walls, floors, and ceilings should have a smooth and easy to clean surface.
3.6 Lighting and Sanitation: Facilities must have sufficient lighting to work properly and effective pest control system. Additionally, the facility needs a sanitation system to maintain cleanliness and the complete safety of the facility.
3.7 Facilities Must Undergo Qualification: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) – These qualifications need to be performed regularly to ensure that the facility continues to operate in compliance with Current Good Manufacturing Practice (CGMP).
4.1 Design Qualification (DQ): This is an evaluation that determines if the equipment design meets all relevant specifications and applicable regulations.
4.2 Installation Qualification (IQ): This is an evaluation to ensure that the equipment has been installed according to the appropriate specifications.
4.3 Operational Qualification (OQ): This is an assessment to confirm the equipment operates within the specified range of operation for the intended purpose.
4.4 Performance Qualification (PQ): This is an assessment to confirm that the equipment produces consistent results during actual operation.
4.5 Preventive Maintenance and Calibrations: Scheduled preventative maintenance and certifications of maintenance provide confidence and assurance that your equipment will perform reliably without failure.
4.6 Status Labels: Every piece of equipment must be clearly identified with a label that indicates whether it has been “Cleaned,” “Under Maintenance,” or “In Use.”
4.7 Utilities Validation: Validation is required on critical utility systems including HVAC, Compressed Air, Nitrogen, Purified Water, WFI, and other systems as needed.
Properly qualified and maintained equipment minimizes downtime and ensures data integrity.
5.1 Qualification of Suppliers: Only vendors who have been approved and audited by company are permitted to supply materials.
5.2 Incoming Material Control: Samples of all incoming materials are required to be tested for quality by Quality Control (QC) personnel prior to being released for production.
5.3 Storage and Labeling: All quarantined materials, approved materials and rejected materials are to be stored in separate locations with clear markings identifying the type of material.
5.4 Environmental Control: Temperatures and humidity in warehouses will be maintained and monitored under controlled conditions.
5.5 Dispensing: Use calibrated scales for weighing materials that are dispensed in controlled areas using Quality Assurance (QA) personnel during dispensing activities.
5.6 Material Traceability: Material traceability will start when the material is received until it is finished product. Proper material management is critical to preventing potential contamination, confusion or use of materials that do not meet specifications.
6.1 Standard Operating Procedures (SOPs): SOPs provide detailed directions for each and every task that is performed in the company.
6.2 Batch Records: Which indicate every stage of production, signed and dated by the operator.
6.3 Logbooks and Registers: which continue traceability of all equipment, utilities, and cleaning done.
6.4 Validation Protocols and Reports: which validate each test carried out with the testing plan and results listed.
6.5 Training and Calibration Records: which provide verification of employee competency and equipment accuracy.
6.6 Good Documentation Practices (GDP): Making sure your entries are legible, accurate and contemporaneous, using permanent ink and not overwriting, signing, dating, and justifying any corrections made on documents, maintaining the most current version of all documents.
All accurate documentation will allow verification of compliance with GMPs during any audits.
7.1 Batch Manufacturing and Batch Packaging Records: All copies are controlled and approved by Quality Assurance.
7.2 Line Clearance: Prior to starting any new production procedures, previous production and operation documents must be removed from the production line.
7.3 In-Process Control (IPC): Periodic sampling and testing of the product to assure that the product is homogenous.
7.4 Environmental Control Monitoring: Environment conditions for example; measuring the level of airborne particulate, determining the viability of the product, and the temperature and relative humidity of the environment in which the product is being manufactured.
7.5 Cleaning Validation: Cleaning validation confirms that the equipment is cleaned to a level where no residual material remains above acceptable product environmental limits.
7.6 Yield Reconciliation: Yield reconciliation verifies that there are no lost materials or materials added without approval.
7.7 Final Batch Review: Before any product is released for market, quality assurance must review all documentation related to the batch.
Validation of the production process assures that all batches of the product are produced uniformly and meet all product specifications.
8.1 Sampling and Testing: Sampling and testing of all raw materials, intermediates and finished products should be carries out by a trained and qualified analyst using validated methods.
8.2 Analytical Method Validation: Analytical methods must be validated to ensure that they provide accurate, precise, linear, and robust results of the products manufactured in the facility.
8.3 Instrument Calibration: HPLC and GC instruments, balances and pH meters are calibrated regularly to confirm their measurement accuracy.
8.4 Stability Studies: Stability studies are conducted on all products to evaluate the product's shelf life at both accelerated and long-term conditions.
8.5 Handling OOS/OOT Results: Investigate the root causes of OOS/OOT results, put the results in writing, and establish trend analyses.
8.6 Reference Samples and Retention Samples: Reference samples and Retention samples are retained for future testing or complaint resolution purposes.
A strong quality control system is the last step before products are made available to customers on the market.
9.1 Process Validation: To ensure that the continual consistency of quality through the manufacture of the product.
9.2 Cleaning Validation: Cleaning validation helps to demonstrate that the cleaning process cleans the item to acceptable levels of contamination.
9.3 Analytical Method Validation: It guarantees that the results of the analytical tests are accurate and reproducible.
9.4 Computer System Validation (CSV): CSV process helps to ensure that computer systems are in compliance with 21 CFR Part 11 and Annex 11.
9.5 Facility and Utility Qualification: The qualification of the facility, and utilities consist of the DQ, IQ, OQ and PQ.
All validation activities must be included in a VMP and approved by Quality Assurance (QA).
10.1 Deviation Management: All unplanned and that do not comply with the standard operating procedures (SOPs) or standard specifications should be recorded. Investigate the root cause of the deviation and classify it as either minor, major or critical on the basis of its impact on the product quality. Implement CAPA and evaluate the effectiveness of this process.
10.2 Change Control: Every proposed change should be evaluated for its impact on product quality. The change must be approved through a cross functional review and then documented and implemented according to trail of quality assurance (QA) oversights.
10.3 CAPA System: Mitigate the risk of recurring problems by applying appropriate corrective (short-term) and preventive (long-term) measures. The status of each CAPA will be tracked for its effectiveness through follow-up audits.
11.1 Create a schedule that covers all of your areas/departments to be audited in the company.
11.2 Review and document the audit based on approved checklists.
11.3 Through the use of these checklists, review and document the results from each of your self-audits; categorize them (Critical/Major/Minor).
11.4 Review results on corrective action taken.
11.5 Management should review audit trends regularly.
Internal audits promote accountability and enhancement among departments.
12.1 Complaints: Make a record to every product complaint whether it is related to quality or safety. Investigate the cause and take controlled corrective action (CAPA). Inform regulatory authorities for critical findings.
12.2 Recalls: It is required to have a written recall procedure. Keep batch distribution records for tracing. Conduct mock recall exercises regularly and recall product from market to check the level of preparation for product recall.
12.3 Returns: Check the quality of returned products to determine if they can be reprocessed or must be discarded. Write down the final disposition (rejected, reprocessed, or destroyed).
An efficient complaint and recall system is important in ensuring the safety of patients and maintaining the trust of the company in the market.
13.2 You must maintain a dispatch log of all products that includes the batch number, quantity and recipient of product.
13.3 Records of shipments must be kept for minimum of 12 months after the expiration date of the product.
13.4 You must use serialization and tamper-proof packaging to reduce the risk of counterfeiting.
13.5 You must maintain the temperature of the product during transit when transporting temperature sensitive products.
The ability to trace products allows you to quickly respond to a recall or an investigation if needed.
14.1 Secure and restrict access to the electronic systems for data entry and data retrieval.
14.2 Maintain a complete audit trail for each record including laboratory instruments.
14.3 Restrict the ability to delete or modify data in computer systems.
14.4 Conduct periodic audits to ensure compliance with the requirements for ALCOA+ compliance.
The integrity of analytical data provides the foundation for credibility of every GMP operation.
15.1 Management Review Meetings: A method for tracking the results of audits, including audit results, deviations, and customer complaints.
15.2 Quality Metrics: Measure the CAPA closure time and the deviation rates and product defect trends.
15.3 Enhanced Training: Identification of competency gaps and providing on-the-job refresher training programs for employees.
15.4 Lean and Six Sigma Tools: Reduce process variability through the optimization of processes.
Building a culture of continuous improvement will help to turn GMP from an obligation for compliance into a competitive advantage for your business.
Good Manufacturing Practices (GMP) are a complete set of elements that combine together to create a Quality Management System (QMS) used to control every part of the making of a pharmaceutical product.
All GMP components, from starting materials to the final product release procedures, provide assurance to patients that all the medicines they receive are safe and effective and consistently provide a good product.
Companies that adopt GMP do not only comply with regulations; they also provide evidence of their commitment to quality and safety and to the building of a relationship of trust with patients.
GMP represents more than simply complying with regulatory requirements, it also represents continued excellence on a consistent basis in all products, every process, and every aspect of the pharmaceutical industry.
The GMP requirements reduce the potential for contamination, product mix-ups, deviation from the standard manufacturing process and final product defects that cannot be identified through testing at the end of the manufacturing process. This means that Quality must be a consideration at every step of the manufacturing process - from receipt of raw materials to distribution of finished product.
Every manufacturer across the globe must comply with the GMP guidelines established by the US FDA (21 CFR Parts 210 & 211), European Medicines Agency (EMA – EU-GMP), World Health Organization (WHO), and the Central Drugs Standard Control Organisation (CDSCO - Schedule M, India).
This article outlines and describes the essential principles of GMP, as well as their importance and relationship to each other and the assurance of quality in the final product.
1. Quality Management System (QMS)
A Quality Management System is the foundation of Good Manufacturing Practices (GMP) compliance, integrating all quality-related activities as a means of assuring the continuous improvement of its Quality System and as a tool to achieve compliance with all applicable regulations.1.1 Quality Policy and Objectives: A quality policy of company establishes a commitment to the safety of its patients and the quality of its products. Quality objectives should be quantifiable and regularly reviewed.
1.2 Quality Manual: It describes the organizational structure, responsibilities and how documents are routed through the system in order to monitor compliance with the quality policies and objectives.
1.3 Deviation, Change Control and CAPA: All deviations must be investigated to determine their root cause and follow-up actions must be taken to prevent their recurrence.
1.4 Management Review: Periodic senior management reviews must assess the quality of the organization using statistical measures such as deviations, complaints, and audit results.
A strong QMS eliminates the need for decisions based solely on conjecture or assumptions and guarantees regulatory compliance throughout the entire product lifecycle.
2. Organization and Personnel
Quality starts with the individuals producing the product.2.1 Organizational Structure: There should be clear responsibilities between quality assurance, quality control department, production department, engineering department and the storage areas of the organization.
2.2 Competence & Training: Individuals must complete initial and on-going training based upon their job responsibilities and their duties when working in a GMP facility.
2.3 Hygiene & Health: All employees must be medically fit and healthy and must wear protective clothing and follow proper personal hygiene procedures.
2.4 Access Control: Access to all areas of the facility, including sterile areas and manufacturing areas, must be limited to authorized personnel only.
2.5 Culture of Quality: Employees must have a culture of quality where they are encouraged to report any discrepancies in the GMP processes and provide suggestions for improvement without any fear.
All personnel who are properly trained and motivated are the foundation of the GMP compliance program.
3. Premises and Facility Design
The Manufacturing Facility has a huge impact on product quality. Good Manufacturing Practices (GMP) state that facility should be properly designed, constructed, and maintained, in order to avoid contamination and mixing up your products.3.1 Logical Flow: The flow of personnel, material, and finished product must be separated from one another to prevent cross-contamination.
3.2 Separation of Areas by Operation: Dedicated areas should be established for the following operations: Dispensing, Granulation, Compression, Coating, and Finishing.
3.3 Classification of Cleanrooms: Facilities must be classified in accordance with either ISO 14644 or EU-GMP (Grades A through D).
3.4 Air Handling Systems: HVAC systems should capable to maintain necessary differential pressures & temperatures between cleanrooms to prevent cross-contamination.
3.5 Surfaces: Walls, floors, and ceilings should have a smooth and easy to clean surface.
3.6 Lighting and Sanitation: Facilities must have sufficient lighting to work properly and effective pest control system. Additionally, the facility needs a sanitation system to maintain cleanliness and the complete safety of the facility.
3.7 Facilities Must Undergo Qualification: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) – These qualifications need to be performed regularly to ensure that the facility continues to operate in compliance with Current Good Manufacturing Practice (CGMP).
4. Equipment and Utilities
Equipment and utilities are essential contributors to the overall quality of products and therefore need to be designed, installed, and maintained with accuracy and precision.4.1 Design Qualification (DQ): This is an evaluation that determines if the equipment design meets all relevant specifications and applicable regulations.
4.2 Installation Qualification (IQ): This is an evaluation to ensure that the equipment has been installed according to the appropriate specifications.
4.3 Operational Qualification (OQ): This is an assessment to confirm the equipment operates within the specified range of operation for the intended purpose.
4.4 Performance Qualification (PQ): This is an assessment to confirm that the equipment produces consistent results during actual operation.
4.5 Preventive Maintenance and Calibrations: Scheduled preventative maintenance and certifications of maintenance provide confidence and assurance that your equipment will perform reliably without failure.
4.6 Status Labels: Every piece of equipment must be clearly identified with a label that indicates whether it has been “Cleaned,” “Under Maintenance,” or “In Use.”
4.7 Utilities Validation: Validation is required on critical utility systems including HVAC, Compressed Air, Nitrogen, Purified Water, WFI, and other systems as needed.
Properly qualified and maintained equipment minimizes downtime and ensures data integrity.
5. Materials Management
Material management includes controlling all source materials used in manufacturing products, including raw ingredients and packaging materials, in accordance with Good Manufacturing Practices (GMPs).5.1 Qualification of Suppliers: Only vendors who have been approved and audited by company are permitted to supply materials.
5.2 Incoming Material Control: Samples of all incoming materials are required to be tested for quality by Quality Control (QC) personnel prior to being released for production.
5.3 Storage and Labeling: All quarantined materials, approved materials and rejected materials are to be stored in separate locations with clear markings identifying the type of material.
5.4 Environmental Control: Temperatures and humidity in warehouses will be maintained and monitored under controlled conditions.
5.5 Dispensing: Use calibrated scales for weighing materials that are dispensed in controlled areas using Quality Assurance (QA) personnel during dispensing activities.
5.6 Material Traceability: Material traceability will start when the material is received until it is finished product. Proper material management is critical to preventing potential contamination, confusion or use of materials that do not meet specifications.
6. Documentation and Record Maintenance
According to GMP, "If something isn't documented, it didn't take place." Always remember this sentence.6.1 Standard Operating Procedures (SOPs): SOPs provide detailed directions for each and every task that is performed in the company.
6.2 Batch Records: Which indicate every stage of production, signed and dated by the operator.
6.3 Logbooks and Registers: which continue traceability of all equipment, utilities, and cleaning done.
6.4 Validation Protocols and Reports: which validate each test carried out with the testing plan and results listed.
6.5 Training and Calibration Records: which provide verification of employee competency and equipment accuracy.
6.6 Good Documentation Practices (GDP): Making sure your entries are legible, accurate and contemporaneous, using permanent ink and not overwriting, signing, dating, and justifying any corrections made on documents, maintaining the most current version of all documents.
All accurate documentation will allow verification of compliance with GMPs during any audits.
7. Production and Process Control
Controlled conditions are necessary for consistency between the different batches of products during production.7.1 Batch Manufacturing and Batch Packaging Records: All copies are controlled and approved by Quality Assurance.
7.2 Line Clearance: Prior to starting any new production procedures, previous production and operation documents must be removed from the production line.
7.3 In-Process Control (IPC): Periodic sampling and testing of the product to assure that the product is homogenous.
7.4 Environmental Control Monitoring: Environment conditions for example; measuring the level of airborne particulate, determining the viability of the product, and the temperature and relative humidity of the environment in which the product is being manufactured.
7.5 Cleaning Validation: Cleaning validation confirms that the equipment is cleaned to a level where no residual material remains above acceptable product environmental limits.
7.6 Yield Reconciliation: Yield reconciliation verifies that there are no lost materials or materials added without approval.
7.7 Final Batch Review: Before any product is released for market, quality assurance must review all documentation related to the batch.
Validation of the production process assures that all batches of the product are produced uniformly and meet all product specifications.
8. Quality Control and Laboratory Operations
Quality control confirms the quality of all raw materials and finished products with established specifications before the release of product into the market.8.1 Sampling and Testing: Sampling and testing of all raw materials, intermediates and finished products should be carries out by a trained and qualified analyst using validated methods.
8.2 Analytical Method Validation: Analytical methods must be validated to ensure that they provide accurate, precise, linear, and robust results of the products manufactured in the facility.
8.3 Instrument Calibration: HPLC and GC instruments, balances and pH meters are calibrated regularly to confirm their measurement accuracy.
8.4 Stability Studies: Stability studies are conducted on all products to evaluate the product's shelf life at both accelerated and long-term conditions.
8.5 Handling OOS/OOT Results: Investigate the root causes of OOS/OOT results, put the results in writing, and establish trend analyses.
8.6 Reference Samples and Retention Samples: Reference samples and Retention samples are retained for future testing or complaint resolution purposes.
A strong quality control system is the last step before products are made available to customers on the market.
9. Validation and Qualification
The processes and systems must perform consistently against previously set specifications.9.1 Process Validation: To ensure that the continual consistency of quality through the manufacture of the product.
9.2 Cleaning Validation: Cleaning validation helps to demonstrate that the cleaning process cleans the item to acceptable levels of contamination.
9.3 Analytical Method Validation: It guarantees that the results of the analytical tests are accurate and reproducible.
9.4 Computer System Validation (CSV): CSV process helps to ensure that computer systems are in compliance with 21 CFR Part 11 and Annex 11.
9.5 Facility and Utility Qualification: The qualification of the facility, and utilities consist of the DQ, IQ, OQ and PQ.
All validation activities must be included in a VMP and approved by Quality Assurance (QA).
10. Handling Deviations, Change Control and CAPA
A robust quality system should have a systematic approach for managing the unexpected events and making improvements.10.1 Deviation Management: All unplanned and that do not comply with the standard operating procedures (SOPs) or standard specifications should be recorded. Investigate the root cause of the deviation and classify it as either minor, major or critical on the basis of its impact on the product quality. Implement CAPA and evaluate the effectiveness of this process.
10.2 Change Control: Every proposed change should be evaluated for its impact on product quality. The change must be approved through a cross functional review and then documented and implemented according to trail of quality assurance (QA) oversights.
10.3 CAPA System: Mitigate the risk of recurring problems by applying appropriate corrective (short-term) and preventive (long-term) measures. The status of each CAPA will be tracked for its effectiveness through follow-up audits.
11. Self-Inspection and Audits
Self-inspection (internal audit) leads to the continuous compliance with GMP prior to a regulatory inspection.11.1 Create a schedule that covers all of your areas/departments to be audited in the company.
11.2 Review and document the audit based on approved checklists.
11.3 Through the use of these checklists, review and document the results from each of your self-audits; categorize them (Critical/Major/Minor).
11.4 Review results on corrective action taken.
11.5 Management should review audit trends regularly.
Internal audits promote accountability and enhancement among departments.
12. Product Complaints, Recalls and Returns
Good Manufacturing Practices (GMP) demand a clear arrangement that explains the way defective or possibly harmful products are handled.12.1 Complaints: Make a record to every product complaint whether it is related to quality or safety. Investigate the cause and take controlled corrective action (CAPA). Inform regulatory authorities for critical findings.
12.2 Recalls: It is required to have a written recall procedure. Keep batch distribution records for tracing. Conduct mock recall exercises regularly and recall product from market to check the level of preparation for product recall.
12.3 Returns: Check the quality of returned products to determine if they can be reprocessed or must be discarded. Write down the final disposition (rejected, reprocessed, or destroyed).
An efficient complaint and recall system is important in ensuring the safety of patients and maintaining the trust of the company in the market.
13. Distribution and Traceability
13.1 You must track each batch from the manufacturer to the customer through the distribution records.13.2 You must maintain a dispatch log of all products that includes the batch number, quantity and recipient of product.
13.3 Records of shipments must be kept for minimum of 12 months after the expiration date of the product.
13.4 You must use serialization and tamper-proof packaging to reduce the risk of counterfeiting.
13.5 You must maintain the temperature of the product during transit when transporting temperature sensitive products.
The ability to trace products allows you to quickly respond to a recall or an investigation if needed.
14. Data Integrity
Data and records in laboratory and production must follow ALCOA+ principles i.e. Attributable, Legible, Contemporaneous, Original, Accurate and Complete).14.1 Secure and restrict access to the electronic systems for data entry and data retrieval.
14.2 Maintain a complete audit trail for each record including laboratory instruments.
14.3 Restrict the ability to delete or modify data in computer systems.
14.4 Conduct periodic audits to ensure compliance with the requirements for ALCOA+ compliance.
The integrity of analytical data provides the foundation for credibility of every GMP operation.
15. Continuous Improvement and Management Review
The evolving practice of Good Manufacturing Practices (GMP) requires a commitment to continuous improvement in order for the system to meet the future challenges of the market.15.1 Management Review Meetings: A method for tracking the results of audits, including audit results, deviations, and customer complaints.
15.2 Quality Metrics: Measure the CAPA closure time and the deviation rates and product defect trends.
15.3 Enhanced Training: Identification of competency gaps and providing on-the-job refresher training programs for employees.
15.4 Lean and Six Sigma Tools: Reduce process variability through the optimization of processes.
Building a culture of continuous improvement will help to turn GMP from an obligation for compliance into a competitive advantage for your business.
Good Manufacturing Practices (GMP) are a complete set of elements that combine together to create a Quality Management System (QMS) used to control every part of the making of a pharmaceutical product.
All GMP components, from starting materials to the final product release procedures, provide assurance to patients that all the medicines they receive are safe and effective and consistently provide a good product.
Companies that adopt GMP do not only comply with regulations; they also provide evidence of their commitment to quality and safety and to the building of a relationship of trust with patients.
GMP represents more than simply complying with regulatory requirements, it also represents continued excellence on a consistent basis in all products, every process, and every aspect of the pharmaceutical industry.
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