Twenty years inside the plant, not outside it
Layouts designed and taken through approval. Quality systems built from the apex documents down. Inspections faced from more than fifteen regulatory agencies. Budgets and investment decisions owned rather than recommended.
Why the progression matters to the work
Selvinium Solutions is led by Himansu Khandhedia, M.Sc. (Chemistry), whose twenty years in the pharmaceutical industry span quality assurance and quality control, production and projects, and distribution and operations — rising from QA Officer to Site Head – Quality Assurance, Deputy and Assistant General Manager – Quality Assurance, and operational leadership at Chief Operating Officer level.
That progression matters to the work. A consultant who has only audited will write a report. A consultant who has held the licence, signed the release, and defended the decision to an inspector writes something a site can act on — because he has had to act on it himself, with the same production pressure and the same budget.
Compliance that was built five years ago does not automatically meet the standard being applied today — and the gap is usually found in the layout, the qualification file and the data, not in intent.
What clients come with
Typically one of four situations: an inspection is scheduled, an observation has landed, a new line or block is being built, or a regulatory change such as the Revised Schedule M has made the current system insufficient. In each case the need is the same — an accurate read on the gap, and a plan that can be executed with the people and the budget actually available.
How the practice is set up
The person who scopes the assignment is the person who does the work. Support is delivered at the plant, off site, or as a continuing arrangement of periodic visits with remote review between them — and wherever possible the site's own team carries out the work under guidance, so that competence stays in the building after the assignment closes.
Roles held, and where the experience was earned
Roles held across twenty years
- Quality Assurance Officer
- Executive — Quality Assurance
- Manager — Quality Assurance
- Site Head — Quality Assurance
- Deputy General Manager — Quality Assurance
- Assistant General Manager — Quality Assurance
- Chief Operating Officer
The progression matters more than the dates. Layouts designed and taken through approval, quality systems built from the apex documents down, inspections faced from more than fifteen regulatory agencies, and the budget behind the compliance owned rather than recommended.
Organisations
- Sun Pharmaceutical Industries
- Cadila Pharmaceuticals
- Ajanta Pharma
- Claris Lifesciences
- Famy Care
- Umedica Laboratories
- Hikal
- Farbe Firma
Sterile injectables, oral solids, oral liquids and active pharmaceutical ingredients — at sites manufacturing for the Indian market and for regulated export.
What that work involved
- Third-party audits conducted
- Excipient manufacturers · active pharmaceutical ingredient manufacturers · contract and public testing laboratories · validation and calibration service providers · packaging material suppliers · sterilisation service providers
- Contract manufacturing oversight
- Qualification and audit of loan-licence and third-party manufacturing sites · technical and quality agreements · oversight of outsourced production and batch release · resolving quality issues at sites not under direct control
- Technology transfer
- Complete transfer of products between sites and to contract manufacturers — process, analytical method, documentation, qualification and first commercial batches, through to steady-state production at the receiving site
Qualifications
M.Sc. — Chemistry
Bhavnagar University · 2005
B.Sc. — Chemistry
Saurashtra University · 2003
Good Cleaning Validation Practices
Destin LeBlanc / Easy Solutions, Mumbai · 2009
Languages
English · Hindi · Gujarati — training delivered in the language the floor works in
What every client is given in writing
Confidentiality
Formulations, layouts, records and commercial information seen during an assignment are treated as confidential, and non-disclosure undertakings are signed as a matter of course.
Independence
No commission, referral or commercial interest is taken from any equipment supplier, instrument maker or vendor recommended — advice follows what the plant needs, not what a supplier is selling.
Continuity of production
Assessment and upgradation work is planned around the production schedule and sequenced so that the plant keeps running.
Your people stay in charge
Wherever possible the site’s own team carries out the work under guidance and review, so that ownership, competence and confidence remain in-house.
The most useful first step is a walk through the plant.
A single visit establishes where a site stands against the standard it will actually be judged by, what must change in the layout, the systems and the records, and in what order those changes should be made. Everything after that is a matter of sequence and execution.