PHARMA PROJECTS
We take designing ,execution and renovation projects related to Pharma Formulation OSD ,Liquid Orals , Sterile facility and API plants.
We do Plot and Contour Planning for new sites ,we designs Plant layout as per regulatory requirements keeping a due consideration for cost effectiveness in Operations. We conceptualize all Layouts i.e. Man /Material Movements , Technical areas , Waste clearance pathways and all related concepts.We provide basis of design for HVAC, Utilities ,Compendial water systems and also give due consideration for future expansion of capacities with growing business. We provides regulatory support in execution of expansion projects on running sites with well conversed Risk assessment documents.
FORSEE POTENTIAL FAILURES
When we talk about Pharma Giants they have well established team and systems which gives a complacency and over confidence resulting in silly mistakes sometimes a blunder which costs millions to the business. We perform a thorough check and study in already established systems and finds the potential for failure and provide our report specific to particular system, our expertise is in anticipation before someone may point the lacuna.
SURVEILLANCE AUDIT
The cost of nonconformance is too high for Pharma Business. As a new concept we have introduced unannounced surveillance audit system for our client’s plants and /or their contract service providers. We will depute our experienced team randomly to the subjected plants with confidential information to only Top Management. We believe that this new concept in Indian Pharma Companies will open up doors for more robust and authentic systems on shop floor and will help to strengthen QMS and ATR.
QMS ,GAP ASSESSMENT AND DUE DILIGENCE AUDIT
Our team of experts from industry and Intercontinental supports are best in doing due diligence audit on different Formulation and API sites. We perform a thorough due diligence audit to find the gaps in the existing system and we provides a comprehensive remediation plan to overcome with any short of deficiencies.
We have expertise to assess all systems i.e Manufacturing, Packaging & Labeling controls , QMS System , Laboratories control system, Material and inventory Control system and Facility and Equipment control system. We also perform specific audit only for Data Integrity. We assess all QMS related documents i.e. Change management systems, Investigations , Market complaint investigations ,Deviation investigations, Adequacy of RCA , Adequacy of Risk assessments, Effectiveness of CAPA system , OOS /OOT investigation strategy of Clients.
QUALIFICATIONS AND VALIDATION
We provide comprehensive supports to define Qualification policies ,Validation master plan ,Guidance to make Qualification Protocol and reports , Qualification of equipments and instruments ,Validation of utilities ,Concepts on Cleaning Validation , Evaluation of Computer system Validation , Process Validation etc.
We also provides supports in Facility Qualification. Qualification of Manufacturing equipment, HVAC qualification , Purified Water Validation. Compressed Air Validation, Process Validation,Cleaning Validation ,Media fill simulation studies, Validation & Calibration Master Plan, adequacy of Vendor Qualification and review on Preventive maintenance.
PREVENTION OF CROSS CONTAMINATION
We are expert in designing and defining prevention of cross contamination in multi product or multi site locations. We have the best way to perform cross contamination studies on the site to demonstrate a risk free site.
OPERATIONAL EXCELLENCE AND COST SAVING
With our vast experience on Plant operations we take cost saving and Operational excellence project s to streamline operations to reduce Operational cost. We perform thorough assessment on utilities and operations and provides way out for Optimizations of capabilities.
PHARMA COACH
We understands the need for guidance to Pharma aspirants .There is huge potential in Pharma Industry but mentoring is the base for all your future success. A person in wrong area may make their professional life difficult .With our expertise in Pharma Horizon we understand the success path for different type of personalities. We suggest what could be best for you . Our counseling is based on mapping of individual and our guidance helps candidates to choose a better area as per their competency. We provide free guidance to all Pharma freshers .Just write to us on freeadvice@pharmacrony.com
With increasing regulations and increased expectations, working in regulatory Pharma plants have become a challenging role . A Pharma professional is continuously working in different work dynamics and work pressure & personal life balance is really a tough process for them .To get achievements we really needs mentor to whom we can discuss and shape up our carrier. If you are looking for a mentor who can guide you with his life enlightening approach please write to us on mymentor@pharmacrony.com
Working in everchanging expectations with frequent upgradation in regulations is creating a huge stress and job dissatisfaction among Pharma Professionals and more than 50% professionals are always looking for a change.They changes organizations but working conditions remains same. Some time we opt for even worse conditions out of our own apprehensions. If you are in the process of job change or you are looking for a job change please write to us before opting a change .Sometime right mentor improves our status and feel good factor in our current job only. If you are a Pharma professional who are in the process of changing the job, write to us before resigning from your current job. We will get a reference check for your future organization with dos and don’ts suggestion so that you will have a pleasant carrier ahead. Please write a mail to us at mymentor@pharmacrony.com
Are you an ambitious Pharma professional with initial experience and want to grow yourself in Regulatory Formulation Plants??. If you are still roaming around conference rooms to learn what the inspectors are asking to your seniors and you are not allowed to create a mass around please come to area of our expertise ,We will create a excellent SME in you.
With our paid services we will develop one of best Pharma technocrat among yourself. We will provide best study materials , presentations and best possible logics to answer all queries upto the level of regulatory expectations.Our coaching will be done as per your convenience of time . To book a slot Send a mail at mymentor@pharmacrony.com
TRAINING AND DEVELOPMENT
Training and Personnel are the key element for the success of any business in Pharmaceutical Industry. We starts with Gap assessments in the training module of any company ,we evaluate the effectiveness of training and gaps between practice and written procedure .We develop SME among potential members of client team and develop at least 2 tier team to better explain the concept.
We creates Interpreters from clients team .Entire process involves rigorous interactions and evaluations for key members to evolve a self managed multiskilling, interactive team.
We also provides individual training to working professionals where they can sharpen their technical skills & knowledge for better competency . We certifies successful candidates on the completion of evaluation .(This is paid service)
RECRUIT A GEM
We provide unique way of recruitment services for different levels in Pharma Industry. We have designated psychological evaluation which involves tricky evaluation to understand attitude of candidate and we also perform reference checks and preliminary technical evaluation before we forward the resume to client. We also perform aptitude test if required by client.