Pharma Consulting Group International (PCGI)

Embrace the Journey of Growth: Personal and Professional Development Life’s journey is a winding path, presenting unexpected challenges and triumphs that shape us into who we are meant to be. Both personal and professional growth are intertwined, offering valuable lessons and experiences along the way. On a personal level, growth emerges from overcoming obstacles, learning from missteps, and venturing beyond comfort zones. Each hurdle builds resilience, while every achievement, no matter how small, bolsters confidence. The journey may be rugged, but navigating life's twists and turns unveils our true potential. Professionally, growth mirrors this pattern by requiring adaptability, the acquisition of new skills, and the pursuit of fresh opportunities. Whether tackling a demanding project or assuming a leadership role, career evolution demands courage and a readiness to explore uncharted territories. By embracing the path taken, you not only uncover your strengths but also areas for further development. Reflecting on our past journeys reveals that every step, regardless of its nature, is integral to our narrative. Embracing this trajectory, be it personal or professional, fosters gratitude for the voyage and fuels motivation for the future road ahead. Growth transcends destination; it encompasses an appreciation of the past. Share your experiences to inspire others on their own paths of self-discovery and advancement! #selfreflection #growth #motivational #personal

This warning letter highlights significant concerns regarding equipment cleaning and maintenance practices at the manufacturing site. The FDA's primary issue is the risk of contamination or product quality alteration due to insufficient cleaning, improper oversight, and failure to maintain proper sanitary conditions. These problems were compounded by visible signs of dirt and damage (like stained ceilings and cracked plaster), which raises concerns about overall facility hygiene.?(https://lnkd.in/e3VKS2RM) ?? Here’s a summary of key points: ?? Inadequate Equipment Cleaning: The manufacturer failed to clean equipment adequately to prevent contamination. The presence of excessive colored residues on equipment labeled as "clean" indicates a failure in the cleaning process, which can lead to material carryover that could alter the quality of the products. ?? Poor Facility Maintenance: The facility was found to be in poor repair, with damaged ceilings and plaster. This compromises the overall cleanliness of the manufacturing environment and suggests a lack of attention to GMP (Good Manufacturing Practice) requirements for maintaining a clean and safe facility. ?? Inadequate Oversight: The response from the manufacturer acknowledged insufficient oversight in ensuring compliance with cleaning procedures. This lack of enforcement regarding daily sanitation procedures led to material build-up on equipment, increasing the risk of contamination. ?? Response Inadequacy: The FDA found the manufacturer's response inadequate, especially in regard to not addressing why personnel signed off on equipment usage logs, certifying that equipment was clean when it was not. This suggests a breakdown in training, accountability, and adherence to GMP protocols. ?? Risk of Cross-Contamination or Product Build-up: Even though the manufacturer claimed that the equipment was dedicated (meaning it was used for a single product to prevent cross-contamination), the FDA highlighted that carryover of materials or product build-up on unclean equipment could still result in impurities that may affect product quality. ? GMP Expectations: ?? Cleaning Procedures: GMP standards require manufacturers to have clearly defined cleaning procedures for all equipment, whether it is dedicated or not. ?? Risk-Based Approach: Cleaning frequency and procedures should align with the risk they pose to product quality. ?? Accountability: Personnel should ensure accurate sign-off on cleaning logs, and equipment usage should only be authorized when the equipment is confirmed to be clean. If you would like further discussion on this issue, particularly regarding how to align operations with GMP requirements or how to enhance your cleaning and maintenance protocols, feel free to reach out! #warningletter #cleaning #GMP #FDA #equipment

Setting meaningful goals is crucial for personal and professional growth. Goals offer direction, enhance motivation, foster development, and bolster confidence. There are two primary goal categories: personal (such as health, relationships, work-life balance) and professional (like career progression, skill enhancement, networking). Employing the SMART framework (Specific, Measurable, Achievable, Relevant, Time-bound) is instrumental in establishing effective goals. Breaking larger goals into smaller, actionable steps enhances manageability and achievability. Consistent tracking and adapting to challenges are vital for sustaining progress. Overcoming obstacles with resilience, maintaining focus, and seeking accountability aid in staying on course. In summary, setting precise and actionable goals is a potent strategy for attaining success, be it for personal satisfaction or career growth. To stay motivated about your goals, celebrating past accomplishments is key. Reflect on what you have achieved to propel yourself forward. What milestones have you reached that have brought you closer to your aspirations ?

Proactive companies recognize the value of continuing their partnership with GMP consultants even after a successful for-cause inspection. ?? For companies that experience unsuccessful inspections, hiring GMP experts becomes essential to help address compliance gaps and remediate issues. Often, the FDA recommends the engagement of GMP professionals to guide the remediation process and conduct independent assessments to ensure full GMP compliance before requesting a re-inspection. ?? Companies focused on maintaining long-term compliance understand the importance of continuous engagement with GMP consultants. These experts not only mentor staff but also enhance internal audit processes and help organizations stay updated on emerging compliance trends. ? At PCGI, we build strong, lasting partnerships with clients committed to sustained compliance.?Contact us today?to learn how we can support your GMP efforts and help your company achieve lasting success. www.pharmacgi.com #GMP #Consultant #FDA #Compliance

Recently published Warning Letter to a foreign drug manufacturing facility provides a summary of signification cGMP violations. The letter starts by citing the failure of the Quality Unit to ensure reliability of the GMP data and that employees understand and adhere to data integrity principles. Specifically, during the inspection, torn batch production records were found in plastic bags in the rooftop and management admitted to “retrospectively” prepare batch production records for the investigators. Similarly, laboratory records lacked raw data to support testing of released drug products.??While the firm-initiated deviations and hired a third-party consultant, the agency found the response inadequate and requested (1) a comprehensive data integrity remediation program and (2) for Executive management to assess the operations to ensure systems, processes, and products conform to FDA requirements. At PCGI, we assist our clients with the implementation of data management programs to ensure the reliability and completeness of the GMP data. These programs include a periodic verification to ensure sustainability and to be inspection ready. Contact me today. www.pharmacgi.com #GMP, #FDA, #WL, #Dataintegrity, #Qualityunit

Recently published warning letter cited the 21 CFR 211.84 requirements for the testing and approval or rejection of components, drug product containers and closures.?Specifically; ? Each component shall be tested for conformity with all appropriate written specifications for purity, strength, and quality. In lieu of such testing by the manufacturer, a report of analysis (COA) may be accepted from the supplier of a component, provided that at least one specific identity test is conducted on such component by the manufacturer and ? the manufacturer must establish the reliability of the supplier’s analyses through appropriate validation of the supplier’s test results at appropriate intervals. While the requirement to perform identity test for each lot of components is straight forward, the interval for the validation of the supplier test results is left to the manufacturer to define and implement.? In an absence of regulatory guidance, at PCGI, I suggest to clients to implement a process that is consistent with the principles of CGMP and risk management. Questions: Is your firm in full compliance with the 21 CFR 211.84 requirements? What is the approach and frequency for the verification of the supplier’s test results ?

A committee from the U.S. House of Representatives recently conducted an analysis of the FDA’s foreign drug inspection program, focusing on outcomes in India and China from 2014 to 2024. The findings revealed significant variation in inspection outcomes, indicating differing levels of inspector skill and thoroughness. There are concerns about possible bribery or fraud affecting these outcomes. The committee has requested the FDA to provide more information for evaluation. www.pharmacgi.com Feel free to share your thoughts on the letter and the issues raised. #FDA #DrugInspections #ForeignInspectionProgram #USHouseCommittee

USFDA has identified an increase in submissions containing unreliable data generated by third-party test labs resulting in rejection or delay on the approval of new devices or drug products. As registered firms, it's crucial to qualify third-party test labs and closely scrutinize all testing data that a firm does not perform itself, especially relating to biocompatibility and other performance testing, that are included in a submission to the FDA. While it may be difficult for firms to know if certain data have been compromised, the FDA expects firms to identify testing results that are improbable or impossible or do not seem consistent with known information about the product. PCGI can assist clients with the implementation of robust supplier management programs including 3rd party labs providing testing services. These programs include initial assessments followed by periodic reviews and on-site audits. Contact us today to ensure your submissions are reliable and approved. #FDA #suppliermanagement #thirdpartylabs

India’s Natco Pharma was hit with a USFDA Warning Letter resulting from an inspection of the Kothur facility in India back in October 2023.??The eight 483 observations centered on a lack of cleanliness of equipment and utensils to prevent contamination with inspectors referencing data that revealed the presence of different drug substances as high as up to about 800 times the acceptance limit and swab samples taken by inspectors showed the?potential for cross-contamination. Additional observations included not having written responsibilities and procedures for the quality control unit, lacking procedures to prevent microbiological contamination, failing to review unexplained discrepancies of batch failures and other record-keeping problems including the destruction of original records and raw data. https://lnkd.in/gck5HFFv ?? At PCGI we assist our clients with the implementation of comprehensive corrective actions to address 483 observations. Contact us today.??www.pharmacgi.com #USFDA #WL #483 #IndiaPharma