Lack of Training and Awareness Across Management and Staff: Says USFDA 483 to Lupin

Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training required to perform their assigned functions

Lack of oversight by firm management, especially QC, QA, Warehousing, Production and IT departments, to ensure employees are performing their required job functions as specified SOPs. During the inspection, (FDA inspectors) observed several instances where it appeared that top management General managers, Supervisors, Specialists, and personnel engaged in the activities related to the manufacture, testing, holding and review procedures, documents, methods, and data could not autonomously answer questions related to their day to day job functions or activities in which they routinely participated or would hastily provide an answer without consideration of the question which was asked. Many employees, including the QA, QC, Warehousing, Production, and Validation Managers, would directly read the procedure from the document without being able to autonomously comment on activities and operations in which they are described to be familiar with and knowledgeable of. Additionally, firm personnel would provide data and evidence which did not support the claims that could provide answers to specific questions asked by the investigators. For example

A. Manager of IT, Deputy General Manager of Engineering, Sr.Executive IT, Manager Validation/QA could not answer / provide justification why System Release certificate and writing Validation summary report was not followed as per established Validation Master Plan (VMP)/ Protocol for the Building Management System validation documents.

B Document VMP-003-INP-00 (Validation Master Plan Manufacturing Software system).

C. On 01/21/2019  during walkthrough of Analytical QC, Deputy General Manager -Quality Control who oversees QC laboratories could not provide us logbook for Refractometer, though he stated logbook is maintained and one of his staff said they are currently using eLogbook. He could not answer if equipment is connected to data acquisition system and how the information captured from the system is documented into the e-Log system. He could not answer how review of entries in e-Log is performed, tried but could not access the system, and finally told he has no access to the e-Log. He has been trained in the SOP and is assigned a “Manager” role in the system.

D. On 1/21/2019 during the walk through of the Analytical QC, Manager QC could not explain the sample management process though asked 3 times rephrasing the question. Then the Managing director, President of Technical Operations and GM Quality asked in different manner / language and it took him nearly 40 minutes to explain the process, though he has been trained in the SOP UNIT2- QC2- 178- 07 (Sample Management of QC Sample Ver.07) on 1/25/2018.

E. On 01/21/2019 during walkthrough of Analytical QC, Executive QC could not tell  when a column #L19000563 was received in QC and it took nearly half an hour with assistance of other personnel to access the SAP system and provide the information, though it is part of his duties to account for incoming laboratory equipment. When queried if column is used for testing (specific) sample, he answered no; but print out from e-column usage logbook provided by Sr.Executive QC shown column is used.

F. On 1/23/2019 Manager QC and officer IT could not access the electronic logbook (Elog) system V.1.0.0 to show User group’s roles and access level which is part of their duties and warranted a conference call with CQA and vendor of software to show the same. The Elog is the data acquisition software used by the firm to capture activities.

G. On 1/24/2019 Sr.GM Corporate IT explained a User name in the format (FirstnameLastname1) is created when global directory already has a user with similar name, but this is not described in the SOP. The firm does not maintain training records for Sr.GM Corporate IT position.

H. On 01/21/2019, Sr.GM Corporate IT and Manager Site IT could not provide a requested User creation form for one of the firm’s administrators. They called Officer Site IT to show the in the eLog software system when Administrator was removed from the system; took him approximately 13 minutes to demonstrate when the vendor/administrator was removed from system (which is part of his job functions and has been trained on the process). His training records revealed that he was trained on the SOP # QC 2- 229-00 [User management and master data creation for Electronic usage log system] on 07/20/2015 and Ver.01 on 10/ 03/ 2015. 

I. Firm does not maintain training records for the GM CQA position. 

J. On 01/16.2019, an apprentice from Quality Control-Microbiology  who identified himself as responsible for collection of samples for routine analysis from Production area could not answer a Yes/No question pertaining to methodology of sample collection when asked repeatedly in English and local vernacular language.

Organizations and leadership should ensure that their personnel at different levels have knowledge and awareness on SOPs (Standard Operating Procedures), routine jobs, are confident about the same rather than only a broad or peripheral understanding. It is not sufficient to have generic Job roles and job descriptions across different levels and positions listing the same broad functions without being specific to the role and person. When new persons and functional managers join the organization, especially in GxP line functions, there should be adequate orientation and familiarization for personnel with the systems and procedures of the firm; gaps in this result in personnel assuming several things without adequately knowing how and why things are being done at the firm – it is not uncommon to see people assume things are being done in the firm similar to how it was being done at their previous employer. Trainings and training evaluations should be meaningful. Many times SOP and procedure training and training evaluation lack depth, the training frequency is too relaxed, training evaluation questions do not reflect true knowledge of the SOP / subject, but are designed to ensure 100% pass. Organization’s should ensure an effective governance mechanism at Functional, Site and Corporate levels. A good Management governance system should have both a Top down and Bottoms up information loop, feedback mechanisms. When Senior / Top Management & Corporate function leaders have only a very broad understanding, without adequate information and feedback on What, Who, Why and How about firms systems and processes, it creates a disconnect. Disconnect between Firms objectives, procedures, processes and results. It leads to compartmentalisation (people working in silos) and lack of ownership of processes across functions and levels in hierarchy, mechanical functioning. Functions such as IT / IT enabled Quality Management Systems may be driven by Corporate Managers and systems; but there should be adequate understanding of such systems by site line leadership and staff and coordination and feedback mechanisms between Site Managers & staff with Corporate functions. Or else site functional leaders and managers focus will be focusing only on day to day line activities with a hands off approach on systems and process. Organisation’s should ensure: 

• Effective systems for SOP and technical training, training evaluation, with defined frequency like once a year  or as and when changes happen. The training evaluation questionnaire should be well structured to reflect a good understanding of the SOP rather than simple questions to ensure 100% pass. People who handle functions on day to day basis should be able to explain SOPs without reading it through (of course one can always refer SOP for clarifying subtle points, but not for describing a function which is carried out day in/day out).
• Well defined Job roles or Job descriptions (JDs) which reflect direct responsibilities handled by each position/person. Avoid generic JDs. Ensure that persons across all levels are trained in the SOPs related to the JD. A matrix of

JD – > Skills required – >SOPs

     will help (and very much available in most Training Management / Learning Management solutions).

• Adequate orientation of personnel (especially new employees) in functions and activities defined in JD. It can help if the templates for JDs provide for updating progressively for the training and familarisation.
• Establish a system for adequate feedback and governance mechanism at different levels –  Organisation / Site / Function level, through review meetings. Procedurise the same with defined agenda and frequency (ideally monthly). This has to be brought in as a cultural change.
• Develop Site level expertise in all systems and functions. These Site level experts should be able to explain processes during audits, while tasks can be explained by personnel performing the tasks.  For Pharma audits are critical, and it matters a lot that people are able to explain to auditors matters clearly.
• Effective internal audits covering each system, and all SOPs. Many times, internal audits are performed more as an obligation rather than as an effective feedback mechanism. Cover all SOPs (performance, compliance, adequacy) though internal audits at least once in a year (deferred frequency). This will help in maintaining SOP awareness and compliance, and in improving SOPs. Management should take internal audits and feedback mechanisms seriously, outcome of internal audits should be reviewed at Organisational level Management Review Meetings (MRMs). An Organisation which report no significant observations in Internal audits, but always has several observations during external audits (customer / agency) is a sure sign of ineffective internal audits. Train the auditors /frequently rotate, develop a pool of expertise to handle internal audits.
• Train the people at different levels in handling of regulatory audits – behaviour, verbal communication, answering questions, transparency and honesty to gain auditors confidence

• Revamping the Training Management system – Review and redefine the JDs. From JDs, identify skills and trainings; Increase periodicity of trainings. It will help to have a good IT enabled training management system. Ensure training evaluation with meaningful questions. Ensure for all levels (from Managing Director to lowest in hierarchy) JDs are defined; trainings are documented.
• Effective employee induction and orientation program for all levels ensuring they go through / are familiarized with all relevant areas. Ensure involvement of the reporting manager in the process (rather than it being only an HR department activity).
• A cultural shift in governance and feedback mechanism. Procedurise functional level, site level and organizational level Management reviews with defined frequency and agenda.
• Effective Internal Audit; Cover all SOPs through the year in internal audits. Provide sufficient time and resources (auditor as well as auditee). Internal audits, outcome and corrective actions and effectiveness should be part of Management reviews at different levels.
• Develop site/function level expertise in all functions including activities driven by Corporate functions (example GxP IT systems / IT enabled Quality Management systems). While management may be at corporate level, site expertise on the processes and system functionalities is important.