Quality management is a cornerstone in ensuring the excellence and reliability of products. At FWQRC-Global GxP & Regulatory Consultant, we firmly believe in Marquardt’s 1984 quality management success triad, comprising of:

#Quality Philosophy and Policy: This is the foundation, embodying our core beliefs and guiding principles that steer our approach to quality.

#Quality Management Systems: Our structured processes and procedures are designed to consistently meet quality standards.

#Quality Technology Systems: We leverage cutting-edge technology to enhance and monitor the quality of our products.

Balancing these three facets is crucial. Each element is interdependent, contributing uniquely to the overall quality landscape. We ensure that equal attention and innovation are infused into each facet, fostering a holistic approach that elevates product quality while ensuring compliance with global standards.

Join us in this journey of uncompromised quality. Your support amplifies our commitment to delivering excellence consistently. Let’s together build a world where quality is not just a standard, but a way of life.

Do you need an advisor, compliance expert, technologist, or ongoing support?

Is there a need for a process expert to create SOPs from cGMP?

Are you looking for an eQMS expert for a software implementation or system import?

Will your organization need to meet compliance requirements by a deadline?

FWQRC has a proven track record in facilitating success for numerous life science organizations.

Contact us to learn more and get the conversation started info@fwqrc.com

#FWQRC #QualityManagement #Excellence #Support #gmp #glp #gcp

The U.S. Food and Drug Administration (FDA) has recently issued a final rule aimed at enhancing our understanding of antimicrobial use in food-producing animals.

This rule focuses on collecting more detailed information about antimicrobial sales and distribution, specifically by species.

Antimicrobials play a crucial role in veterinary medicine, but their use must be judicious to prevent the development of antimicrobial resistance.

The FDA recognizes the importance of monitoring and regulating antimicrobial use in food-producing animals to safeguard public health.

Diagnosis and Monitoring:

The final rule seeks to achieve the following objectives:

Detailed Information: By requiring animal drug sponsors to submit species-specific estimates of antimicrobial sales, the FDA aims to gain a clearer picture of how these drugs are used in major food-producing species (such as cattle, swine, chickens, and turkeys)

Targeted Efforts: Armed with this data, the FDA can better target its efforts to ensure the judicious use of medically important antimicrobials. This means promoting responsible use while minimizing the risk of resistance development.

Effectiveness Measurement: The collected information will also help the FDA assess the effectiveness of its efforts in regulating antimicrobial use.

The final rule includes the following provisions:

Species-Specific Estimates: Animal drug sponsors must provide sales data broken down by species. This means reporting the quantities of antimicrobials sold or distributed for each type of food-producing animal.

Timeliness of Reporting: To improve transparency, the FDA will publish an annual summary report of antimicrobial sales and distribution information by December 31 of the following year. This ensures that stakeholders have access to up-to-date data.

#antimicrobial #resistance #AMR #animaldrug #gmp #verterinary #auditor #leadauditor #gapanalysis #gapassessment #riskanalysis #capa #qa #qc #qms #qualitycompliance #regulatorycompliance

Concept 1: Product and Process Understanding

The journey begins with a deep dive into the product or business process at hand. Whether it’s manufacturing or a regulated business operation, understanding its intricacies is paramount. #Automation control systems play a crucial role in maintaining Critical Process Parameters (#CPPs), ensuring that Critical Quality Attributes (#CQAs) are not just met but exceeded. Documented system requirements and specifications become the north star, illuminating the path to capturing this essential understanding.

Concept 2: Life Cycle Approach

With foundations rooted in product and process comprehension, we transition into the #lifecycleapproach—a systematic journey from planning to retirement of the system. This approach isn’t just about compliance; it’s an odyssey that enhances system quality and effectiveness. Early identification of issues becomes a cornerstone, reducing costs and enhancing efficiency.

Concept 3: Scalable Life Cycle Activities

But no two journeys are alike—the life cycle is not rigid but scalable. It adapts to varying complexities and scopes associated with different computer systems supporting regulated processes. This flexibility ensures that activities align with the risks posed by each unique system.

Concept 4: Science-Based Quality Risk Management

At its core lies science-based quality risk management—a meticulous application of risk assessment throughout the life cycle. Rooted in objective evaluations focusing on patient safety, product quality, and data integrity, this concept ensures that risk management isn’t static but dynamic.

Concept 5: Leverage Supplier Involvement

The final piece of this intricate puzzle involves leveraging supplier involvement—an often-underestimated asset in this journey. By tapping into technical expertise from suppliers who adhere to good engineering practices and robust internal quality management systems, organizations can streamline testing processes while upholding stringent compliance standards.

Together these five concepts weave a comprehensive tapestry for navigating through computer system validation—each thread integral to crafting an effective framework rooted in compliance yet flexible enough to adapt to diverse landscapes

#food#drugs#cosmetcis#medicaldevices#auditor#gapanalaysis#riskanalysis#riskassessment#capa#qms#qa#qc#qualitysystem#qualitycompliance#regulatorycompliance#consultant#pharma#mpharmaceuticals#meidicnalproducts#trendingnow#trendingpost#gamp5#csv#computersystemvalidation#gmp#gxp#IRCA#CQI#leadauditor

What is a Mock Recall?

A mock recall is a simulated exercise conducted by pharmaceutical companies to evaluate the effectiveness of their recall procedures. It involves tracing and retrieving a specific batch of a drug from the market without actually removing it. The goal is to identify any weaknesses in the recall process and to ensure that if a real recall were necessary, it could be executed swiftly and effectively.

Regulatory Framework

It is important for pharmaceutical professionals to consult the specific guidelines and regulations applicable in their region and for their products. The Central Drugs Standard Control Organization(#CDSCO) in India has established guidelines for recalls and rapid alert systems, which include mock recalls. The #EMA coordinates the assessment of reports of product quality defects for centrally authorized medicines in Europe. The #FDA has regulations under 21 CFR Part 7 that cover voluntary and mandatory recalls. The regulations also suggest that companies should conduct mock recalls to ensure that their recall procedures are effective.

Best Practices for Conducting Mock Recalls:

#Frequency: Conduct mock recalls at regular intervals, at least once every two years, to ensure continuous readiness.

#Scope: Include products with the longest distribution chain to test the recall process across all levels of the supply chain.

#Documentation: Keep detailed records of the mock recall process, including the identification of the batch, the distribution path, and the time taken to complete the recall.

#Evaluation: After the mock recall, evaluate the effectiveness of the recall and make necessary adjustments to the recall plan.

Mock recalls are an essential component of a robust quality management system in the pharmaceutical industry. By adhering to the regulations and best practices, pharmaceutical companies can ensure they are prepared to protect public health in the event of a product quality issue.

#food #drugs #cosmetics #medicaldevices #auditor #qualitycontrol #mockrecalls #qualitycompliance #injectables #drugproducts #API #regulatorycompliance #qualityconsultant #regulatoryconsultant #qms #qa #qc #gapanalysis #riskanalysis #capa #remediation #gmp #qms #trendingpost #trendingnow #trendingreels #riskmanagement

The #recall of medicinal products is a critical process in the #pharmaceutical industry, aimed at protecting public health by ensuring that #medicines on the market meet the highest #quality standards. This blog post will explore the #regulations and procedures surrounding the recall of medicinal products.

What Triggers a Recall?

A medicinal product recall is typically triggered by the identification of a quality defect that could potentially harm patients. 

This defect might be related to the product’s #manufacturing, #packaging, or #contamination issues. 

The defect could be identified by the #manufacturer, #healthcare #professionals, #patients, or #regulatory authorities.

Regulatory Framework:

In the European Union, the European Medicines Agency (#EMA) coordinates the assessment of reports of product quality defects for centrally authorized medicines. 

Marketing and manufacturing #authorization holders are obliged to report any suspected quality defect that could result in a recall or abnormal restriction on supply.

In India, the Central Drugs Standard Control Organization (#CDSCO) oversees product recalls. The CDSCO provides circulars and guidelines on the recall process, ensuring that defective products are efficiently removed from the market.

Recalls are classified based on the severity of the health hazard they pose. For instance, in the United States, the Food and Drug Administration (#FDA) classifies recalls into three categories: 

Class I: Dangerous or defective products that predictably could cause serious health problems or death.

Class II: Products that might cause a temporary health problem or pose a slight threat of a serious nature.

Class III: Products that are unlikely to cause any adverse health reaction but violate FDA labeling or manufacturing laws.

The recall process involves several steps:

Identification: A defect is identified, and a recall is deemed necessary.

Notification: #Regulatory authorities and the public are notified about the recall.

Recovery: The defective products are returned to the manufacturer or disposed of.

Investigation: An #investigation is conducted to determine the cause of the defect.

Corrective Actions: Measures are taken to prevent the recurrence of the problem.

Reporting Obligations: Manufacturers must report quality defects to the relevant regulatory authorities. In the #EU, this includes any prohibition or restriction imposed by the competent authority of any country where the medicinal product is marketed.

The recall of medicinal products is a complex process governed by stringent #regulations. 

It is essential for manufacturers to have robust #quality control systems in place to prevent the need for recalls. 

However, when recalls do occur, they must be managed efficiently to protect patient #safety and maintain public trust in the pharmaceutical industry.

#food#drugs#cosmetics#medicaldevices#auditor#auditingservices#gmp#leadauditor#IRCA #QA #QC #QMS #qualitycompliance #regulatorycompliance #regulations #gapanalysis #riskassessment #riskmanagment #consultingservices #consultant #consultancy #pharma #pharmaceuticals #trendingnow #trendingpost #trendingnews

Cleaning process validation is a critical aspect of pharmaceutical manufacturing. It ensures that the cleaning procedures employed between different production runs are effective and reliable, minimizing the risk of cross-contamination.

What is Cleaning Process Validation?

Cleaning process validation is a scientific technique that provides documented, risk-based evidence that a typical cleaning method will consistently clean the equipment or a medical device in compliance with its predetermined specifications and quality attributes.

It ensures that previous product traces have been removed, operations are contamination-free, and safe batch-to-batch transitions are possible.

Importance of Cleaning Process Validation:

Cleaning validation is essential for ensuring that the cleaning procedure for pharmaceutical products meets defined safety and accuracy standards. It can also detect possible flaws in the manufacturing process, allowing them to be addressed before they cause major damage to the product.

Proper equipment cleaning during the medicinal product manufacturing process is critical for maintaining product quality, preventing contamination, and ensuring patient safety. Let’s delve into the importance of this process:

Product Integrity Preservation:

High-Value Products: Pharmaceutical products have significant financial value for developers and are crucial for patient treatments.

Contaminant Avoidance: Contaminants must be avoided at all costs to maintain product integrity.

Supply Chain Impact: Insufficient care can lead to contaminants entering the drug product supply chain, resulting in costly failures and potential recalls.

Cross-Contamination Prevention:

Mono-Product Processes: For processes involving a single product, visual inspection alone is often adequate for cleaning validation or verification.

Multi-Product Processes: In multi-product operations, the risk of cross-contamination is higher.

Scientific Approach: Cleaning limits based on a scientific approach (such as Health Based Exposure Limits) must be set.

Shared Equipment Train: These limits should be integrated into the shared equipment train.

Control Alignment: Control levels (including sampling and detection methods) should align with the product type and equipment visibility.

Equipment Cleaning Practices:

Changeover Cleaning:

Equipment used for different products during campaigns should undergo thorough cleaning.

Interval Cleaning:

Regular cleaning during a campaign, as necessary.

Dedicated End-of-Campaign Cleaning:

Ensures equipment is ready for the next batch.

Remember, effective equipment cleaning on direct or indirect product contact surfaces is essential to prevent cross-contamination and maintain product quality throughout the manufacturing process.

Solvent Requirements for Equipment Cleaning Process:

The choice of solvent for the cleaning process is crucial.

The most common and practical solvent is water due to its non-toxicity, cost-effectiveness, and environmental friendliness.

However, in some cases, it may be preferable to use a non-aqueous solvent or a combination of both aqueous and non-aqueous solvents due to the solubility characteristics of the materials. Organic solvents such as methanol, toluene, acetone, and ethyl acetate are also commonly used.

Analytical Test Method Requirements:

Analytical methods used in the cleaning validation process should be validated according to the requirements of regulatory bodies like the FDA and EMA.

The four most common types of analytical methods, each with its own set of validation requirements, are identity tests, quantitative tests for impurity content, limit tests for the control of impurities, and potency tests.

The detection limit for each analytical method should be sufficiently sensitive to detect the established acceptable level of the residue or contaminant.

Procedure for Establishing MACO Values:

Maximum Allowable Carryover (MACO) refers to the acceptable amount of a product that can be carried over from one batch to the next.

The correct calculation of MACO is vital for the integrity and success of the cleaning validation program.

MACO can be calculated using various industry-recognized approaches such as health-based, therapeutic, toxicological, and 10 parts per million (ppm) methods.

For example, one common formula for calculating MACO using Permitted Daily Exposure (PDE) is:

  MACO = {PDE x MBS}/{MDD}

  where:

  MACO: Maximum allowable carryover in mg

  PDE: Permitted daily exposure of the previous product

  MBS: Minimum batch size for the next product in mg

  MDD: Maximum Daily dose of the next product in mg

Limit to Control the Carryover of Residual of Previous Products:

The limit to control the carryover of residual of previous products is established based on the MACO value.

This limit ensures that the amount of residual product left on the equipment after cleaning does not exceed the MACO value.

If the calculated MACO limit is not measurable by validated analytical methods, several options can be considered, such as dedicating the equipment to one product, modifying the parameters of the next manufactured product, modifying the sampling parameters, lowering the rinse volume for rinse sampling, or concentrating the rinse sample.

In conclusion, cleaning process validation is a crucial step in assuring quality during pharmaceutical manufacturing. It helps ensure that the cleaning procedures employed are effective and reliable, thereby minimizing the risk of cross-contamination.

#food #drugs #cosmetics #medicaldevices #medicinalproducts #api #qa #qc #ra #reugulatoryaffairs #qualitycompliance #regulatorycompliance #trendingnow #trendingposts #riskanakysis #gapanalysis #riskassessment #capa #remediation #auditor #leadauditor #irca #cqi #pharamceuticals #industries #clv #amv #cleaningvalidation #analyticalmethodvalidation #csv

#Media Fill, also known as Aseptic Process Simulation (#APS), is a method used to evaluate the capability of #aseptic processing activities.

It involves using a #sterile microbiological growth medium in place of the actual product during the simulation.

This process is designed to mimic the routine aseptic manufacturing process as closely as possible, including all critical manufacturing steps.

The goal of a #MediaFill is to test whether the aseptic procedures are adequate to prevent #microbiologicalcontamination during the actual process.

Media fills may be used to evaluate aseptic #techniques used in the assembly of pre-sterilized components and to qualify operators for aseptic techniques.

A typical Media Fill process involves the following steps:

#Selection of Medium: The nutrient medium should be selected based on the #dosage form of the product and the selectivity, clarity, concentration, and suitability for #sterilization of the nutrient medium.

#Simulation Test: This test should be performed at least annually by each person authorized to compound in a low-risk level environment under conditions that closely simulate the most challenging or stressful conditions encountered during compounding of low-risk level CSPs.

#Incubation Period: The filled containers should be incubated at 20° to 25° or at 30° to 35° for a minimum of 14 days.

#Evaluation: After the incubation period, the containers are inspected for microbial growth.

The target for a Media Fill test should be zero growth. However, the acceptable limits for contaminated units are as follows:

When filling fewer than 5000 units, no contaminated units should be detected.

When filling 5000-10000 units, one contaminated unit should result in an investigation, including consideration of repeat media fill. Two contaminated units are considered cause for #revalidation.

In conclusion, Media Fill is an essential tool in the #pharmaceutical and #biotechnology industries for #validating aseptic #manufacturing processes.

It helps ensure that the aseptic procedures are adequate to prevent #contamination during actual #drug production, thereby ensuring the #safety and #efficacy of the final product.

#food#drugs#cosmetics#medicaldevices#auditor#gmp#glp#qa #qc #qualitycompliance #regulatorycompliance #capa #gapanalysis #remediation #irca #cqi #leadauditor #gapassessment #injectables #drugproducts #medicinalproducts #trendingpost #trendinnews #trendingnow

#MoCRA is a law that expands the #FDA’s authority to regulate #cosmetics in the US. It aims to ensure the safety of cosmetic products that many consumers use daily.

On average, people use 6 to 12 cosmetics products daily, including #makeup, #nailpolishes, #shavingcream and other #grooming products, #perfumes, #face and #bodycleansers, #haircare products, #moisturizers, and other #skincare products.

KEY TERMS IN MoCRA:

Adverse Event: Any health-related event associated with the use of a cosmetic product that is adverse.

Facility: Any establishment (including an establishment of an #importer) that #manufactures or processes cosmetic products distributed in the #UnitedStates.

Responsible Person: The manufacturer, #packer, or #distributor of a cosmetic product whose name appears on the label of such cosmetic product.

Serious Adverse Event: An adverse event that results in serious health consequences.

MoCRA provides new authorities to FDA including:

Records Access

Mandatory Recall Authority

MoCRA establishes the following new requirements for industry:

Adverse Event Reporting: A responsible person is required to report serious adverse events associated with the use of cosmetic products in the United States to FDA within 15 business days.

Facility Registration: Manufacturers and processors must register their facilities with FDA and renew their registration every two years.

Product Listing: A responsible person must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.

Safety Substantiation: Companies and individuals who manufacture or market cosmetics have a responsibility to ensure the safety of their products.

A responsible person is required to ensure and maintain records supporting adequate safety substantiation of their cosmetic products. Manufacturers can use relevant safety data that is already available to support the safety of their products.

Animal testing is not a requirement for marketing a cosmetic product.

MoCRA also requires that industry comply with regulations that FDA will establish for:

Good Manufacturing Practice (#GMP) requirements for facilities that manufacture cosmetic products.

#Fragrance#allergen labeling requirements.

Standardized #testing methods for detecting and identifying asbestos in talc-containing cosmetic products.

#food#drugs#cosmetics#medicaldevices#auditor#leadauditor#facilityregistration#productlisting #responsibleperson #gapanalysis #riskassessment #trendingnow #trendingpost #consultants #qualitycompliance #regulatorycompliance #qa #qc #rq #irca #cqi