Indian companies are experiencing difficulties with the US FDA particularly with Process qualifications, cleaning validation, good documentation practices, training, investigation reporting, CAPA and data integrity issues.
These elements are resulting in a plethora of Warning Letters and in some cases Consent Decree situations.
At Smart Pharmaceutical Consulting we have modern efficient approaches to resolving all these issues.
Unlike other companies, we favour a Process Excellence grounded approach to quality compliance resolutions as this provides a faster, more responsive and sustainable approach which is not financially onerous to companies.
Whether you have Warning Letters or something more serious, Smart Pharmaceutical Consulting has the expertise to address your issues.
Come learn about our approaches and fast track your remediation needs.
A Standard Compliance Program
Do you have an integrated and standardized Compliance Program to deal with your issues? If not you need to re-think your approach in relation how you operate your manufacturing facilities.
Today, pharmaceutical companies are frequently confronted with operating issues, both technical and personnel related, which impact the compliance of their manufacturing facilities. Without a coordinated operating strategy to handle such issues as they arise, programs which ordinarily should be straight forward to handle can be compounded and may rapidly lead to a crisis which impacts the reputation of the company and its revenues.
If you don’t have a strategy to support this, then the risk to your organization increases exponentially.
Mitigate this risk by speaking to us today. We have the tools to make your concerns manageable.
Today more than at any time in the past, it’s vital that we create customer value. How we do that with our pharmaceutical processes is to properly manage those integrated actions that produce results consistently in the most efficient ways, with only the resources that are actually needed, nothing more and nothing less.
The competitive environment of the life sciences industry is constantly changing, so organizations need to alter their operating habits to meet the compelling dynamics of the marketplace, if they wish to remain competitive.
Creation of value is often driven by a keen understanding of key performance indicators (KPI’s) and how they are affected by external influences and pressures.
Translating this into a winning Future State is achieved through evaluating these KPI’s against a best practice and then continually refining the situation in accordance with a Kaizen continuous culture philosophy.
At Smart Pharmaceutical Consulting we have the talent and experience to give you the competitive edge to enable your market leadership aspiration.
Call us at 1 (844) 593-LEAN (5326) Or (610) 344-9218
Lean Laboratory Design and Operations
Today the modern pharmaceutical facility requires a nimble efficient QC Laboratory to support production operations.
At a time when many companies are experiencing very high levels of laboratory deviations, incidences and other non-conformances, the task at hand to correct these issues can become very onerous financially and time consuming.
Both of these factors can render your company non-competitive and result in the loss of important contracts. If this involves export materials to Europe or the US for example, then such situations involving egregious faults can lead to import bans. Presently there are over 30 Asian companies involved in import bans in the US.
Upon analysis, we find that many of these issues can be frequently attributed to the design of the laboratory and how it is operated.
If the facility, the layout and laboratory are less than advantageous to efficient, mistake free operations, technicians and analysts involved in playing catch up will cause more errors as they hurry up to clear the growing backlog of samples.
Adding more and more FTE’s is not the solution, as this can encumber an already inefficient situation.
There is a better way and that’s to drive quality compliance by re-designing the space and operating practices to operate in a streamlined way with smooth flow. This will result in analyses with fewer mistakes.
Driving compliance through Lean operation is a relatively new concept that works because both Lean and Quality compliance operate from common principles of standardized repeatable operations with predictable outcomes.
Smart Pharmaceutical Consulting is in India. We are working with Indian companies to implement this approach which is resulting in fewer than 483 observations and higher productivity.
Data Integrity Issues?
If you have experienced data integrity issues then we have the help you need at Smart Pharmaceutical Consulting.
We are experts in dealing with these issues and even provide support to the FDA.
If you’ve experienced a Whistleblower event, have a Warning Letter or have internal audits highlighting problems, we can help you resolve your issues speedily.
Whether the problems are due to:
- Poor internal quality problems
- Weak investigation policies and a lack of training/experience in conducting investigations
- A defective Quality culture organizationally
We have the right blend of technical compliance and legally trained team members to resolve your issues.
Using Smart Pharmaceutical Consulting as your partner you will receive side by side coaching and mentoring in the latest approaches to investigations and problem solving.
You will learn how to use Process Excellence principals to drive your remediation program and change your Corporate Culture.
We will advise your technical and executive team about the “Park Doctrine” and how corporate behavior of executives and employees can have themselves held personally liable for their actions under the Food Drug and Cosmetic Act.
We will develop an over arching Corporate Compliance Approach for you that will put your company on the right track and prevent it from falling into similar issues in the future. This will be part of a Powerful Integrated Forward Strategy Approach.
Call us @ (610) 344-9218 (US) to find out more.
Toll free @ (844) 593-LEAN