Q1. To begin, could you briefly describe your career history and how your work across quality control, quality assurance, and corporate QA roles has evolved over time?

From my experience, my career has developed step by step across Quality Control, Quality Assurance, and Corporate QA, mainly within pharmaceutical and regulated environments. 

In QC, my focus was very much on working in line with pharma guidelines and regulated markets, ensuring day to day testing, compliance, and data correctness. This is where I acquired a deep understanding in understanding how laboratory results directly impact product release and patient safety.

When I moved into QA, the scope widened significantly. I became responsible for control over all factory processes, making sure there was documented evidence for every activity, fully aligned with GMP guidelines, ICH, USFDA, EU, and other global regulatory expectations. This included reviewing batch records, managing deviations, handling change control, and making sure that systems were not merely compliant on paper but defensible during inspections.

In my Corporate QA role, my responsibility became more oversight driven and risk focused. I was expected to keep a close eye on in process metrics throughout production, QC, QA, PPIC, stores, and warehouse areas. From my experience, internal audits, vendor audits, and third party audits are absolutely mandatory, not optional. Without them, it is impossible to maintain real control over quality risks.

Alongside this, I have led quality strategy development, ensured regulatory compliance, managed health authority interactions during inspections, planned and executed internal and external audits, developed and enforced QMS and SOPs, and led, trained, and mentored CQA teams. Continuous improvement through CAPA, risk management, and trend analysis has also been a constant part of my role, along with vendor and supplier qualification and compliance.

 

Q2. Where do GMP or GLP requirements most often get interpreted correctly on paper but applied inconsistently in practice?

From what I have seen over the years, the biggest disconnect between written requirements and real practice sits around data validity and documentation, despite how clearly GMP and GLP define expectations.

On paper, companies fully commit to ALCOA plus principles, but in practice, records frequently becomes desk dropped, meaning entries are completed after the activity rather than at the time it actually occurred. This leads to backdating of records, use of shared or generic logins, and heavy reliance on unvalidated Excel spreadsheets instead of properly validated systems like LIMS.

In QC laboratories, procedures are usually very detailed, but consistency breaks down when there is pressure to release batches. I have seen out of specification results not investigated immediately, or unauthorized retesting carried out until a passing result is achieved. In microbiology, contamination events are frequently traced back giving rise to inconsistent gowning practices or cleaning procedures, even though SOPs are well written.

With equipment and calibration, records may show calibration is complete, but actual maintenance and performance do not always match the documentation. Grace periods are misinterpreted, and non-validated equipment, such as temperature controlled ovens without proper mapping, continue to be used.

Instruction is another area where gaps appear. Although SOPs state that personnel are trained, training often becomes a read and sign exercise instead of a competency based assessment. Over time, experienced staff develop routine blindness, taking shortcuts without identifying the risk.

Deviation investigations are also well described procedurally but weak in execution. Too many investigations are closed with superficial root causes like human error, without identifying the deeper system failures.

In GLP environments, deviations occur when study protocols are not fully understood or followed, and when test articles are mislabeled, mishandled, or poorly controlled.

 

Q3. What early compromises made to maintain delivery dates or supply continuity later create recurring quality issues?

From my experience, many recurring quality problems can be traced back to compromises made very early to protect delivery dates or supply continuity.

A common example is rushing or skipping proper process validation, particularly PPQ batches, to meet accelerated launch timelines. The result is unpredictable product behavior during commercial manufacturing, repeated OOS results, and recurring defects such as tablet capping or lamination.

Another compromise happens in R and D, where production processes are not fully defined before transfer to manufacturing. Sensitivities to temperature, humidity, or environmental conditions go unrecognized, leading to chronic contamination or stability failures later.

On the supply side, relying on a single API supplier, or failing to perform comprehensive audits to speed up procurement, often leads to variable purity, unknown impurities, and potency failures. Using less than optimal excipients to avoid shortages can later affect dissolution profiles and bioavailability.

In manufacturing, using existing equipment or facilities that are not well suited for new products to save capital costs often results in mechanical failures, worn punches and dies, and recurring tablet defects. Weak or manual cleaning validation increases the risk of cross contamination, especially in multi product facilities, which can eventually lead to recalls.

Documentation shortcuts add to the big role. Allowing light data recording or paper based systems early on leads to incomplete batch records and poor traceability. Closing nonconformities or OOS investigations quickly without proper root cause analysis ensures the same issues will repeat.

 

Q4. How do gaps between vendor documentation and actual execution typically surface, and what usually exposes them?

From my experience, gaps between vendor documentation and actual execution usually surface only after a quality issue occurs. Many industries limit or delay audits, even though audits are critical, and this directly impacts patient safety.

These gaps become visible through recurring OOS results, unexplained product variability, and vague investigations that blame operator error without fixing the process. During internal, external, or regulatory audits, it often becomes clear that what is happening on the shop floor does not match what is written in SOPs.

Data validity reviews expose mismatched timestamps, shared logins, and backdated entries. Technology transfers frequently reveal undocumented process knowledge when results cannot be reproduced at a new site.

Regulatory inspections are often the strongest trigger. Inspectors quickly identify missing signatures, incomplete cleaning validation, and poorly maintained equipment. For cause vendor audits following quality failures frequently uncover weak QMS, outdated SOPs, or unauthorized practices.

Unexpected contamination, changes in personnel or manufacturing sites, and deeper audit trail reviews also expose execution gaps that documentation alone cannot hide.

 

Q5. Where do investigation metrics or closure timelines give a false sense of control while fundamental risks remain unresolved?

In my experience, this usually starts with lack of knowledge or understanding of SOPs and training gaps.

One of the most common warning signs is the repeated use of human error as the root cause. Deviations are closed on time, retraining is completed, and metrics look good, but the underlying system issues such as poor SOPs, workload pressure, or equipment design problems remain.

Strict 30 day deviation closure timelines also create risk. Complex investigations require time, and forcing closure leads to shallow root cause analysis and weak CAPAs.

High numbers of invalidated OOS results often hide testing errors, instrument issues, or real manufacturing failures. Low CAPA recurrence rates may indicate that effectiveness checks are weak or missing.

Another sign is the overuse of minor deviation classifications to meet timelines. When near misses and trend data are ignored, early warning signals are lost until a major event occurs.

 

Q6. How do late stage stability indicators or market complaints reveal weaknesses that were not evident during development?

From my experience, long term stability studies reveal issues that accelerated studies simply cannot predict. Real time data over several years shows slow degradation, polymorphic changes, or scale related effects that are not visible during development.

Development stability samples are usually pilot scale. Full commercial scale manufacturing brings in slight changes in moisture content, compression forces, and tablet hardness that affect long term stability.

Packaging interactions such as leachables, extractables, and moisture ingress often appear only after extended storage. Variability in excipients can also trigger unexpected degradation.

Market complaints provide real world feedback. Products are exposed to temperature fluctuations, humidity, shipping stress, and patient handling that cannot be perfectly simulated. Complaints often identify physical defects, contamination, degradation, and packaging or labeling failures that only emerge at scale.

The key difference is that development happens within regulated conditions, while the market does not.

 

Q7. If you were advising senior leaders responsible for quality governance today, what uncomfortable question should immediately raise concern?

From my experience, one of the most concerning answers a leader can hear is:

“We have not audited their subcontractors because they are under NDA or considered proprietary.”

This immediately signals a lack of supply chain visibility. If subcontractors cannot be audited, there is no way to confirm GMP compliance, data authenticity, or material quality.

This often hides weak QMS, poor record-keeping methods, and lack of validation. Regulators hold the license holder responsible for the entire supply chain, and hidden suppliers become hidden risks that can lead to recalls, shortages, or patient harm.

Leadership should insist on quality agreements that include audit rights for tier two and tier three suppliers, request evidence of third party audits, and assess geopolitical risks associated with subcontractor locations.