Approvals move faster
Layouts drawn to the regulation the first time, with flow, classification and segregation defensible on paper before construction begins — so a block is not rebuilt after a review.
Pharmaceutical plant projects, GMP & quality systems
Plants, systems and records that hold up to the standard you will actually be judged by.
Plant layout design and regulatory approvals, total quality management systems, qualification and validation, GMP documentation and inspection readiness — delivered on site and remotely, from active ingredients to sterile finished dosage forms.
The practice
Led by a practitioner who has run these functions inside the plant.
Selvinium Solutions supports pharmaceutical manufacturers in building plants, systems and records that hold up to the standard they will actually be judged by.
The work spans plant layout and project approvals, quality management systems, qualification and validation, GMP documentation and inspection readiness — across active pharmaceutical ingredients, oral solids and liquids, and sterile parenterals.
It is led by a practitioner who has run these functions inside the plant rather than advised on them from outside, and who has been answerable for the compliance and for the budget behind it.
What an engagement delivers
Six things that change on the ground
Not deliverables on an invoice — the differences a client can point to a year after the assignment closes.
Inspection becomes routine
Systems, records and people held in a state where an audit is an ordinary working day rather than three weeks of preparation and a month of responses.
Investment follows risk
Capital directed first at what protects a licence, a batch and a market. Spending is sequenced, not scattered, and nothing is over-engineered to impress an auditor.
The team owns the system
Documents written to be run and defended by your own people, with training delivered on the floor in the language they work in — so capability remains after the assignment closes.
Markets open
WHO, EU and US expectations built into the plant, the system and the dossier together, so approvals and customer audits stop standing between you and the next market.
Plant health becomes visible
Quality indicators and a management information system that show the true condition of the plant on one page — while there is still time to act on it.
The standard being applied today
Compliance built five years ago does not automatically meet the standard being applied today.
Revised Schedule M is in force and CDSCO has directed State authorities to inspect against it. Sterile manufacturing is now assessed against the revised EU GMP Annex 1, data integrity is examined in practically every inspection, and customer audits probe the same ground as regulators.
The gap is usually found in the layout, the qualification file and the data — not in intent. That is where an assessment starts.
Capability
Full capability statement Six areas of work
01
Plant layout, projects & regulatory approvals
Layouts drawn to the regulation that will judge them — for new facilities and for plants being reworked inside existing walls.
02Total quality management system
Apex documents that state what the organisation stands for, and the working procedures that make them true every day.
03Qualification & validation
The full lifecycle from user requirement to periodic review — written so that the file proves the work was done.
04GMP documentation — the complete library
One coherent document set that satisfies the State authority, a WHO or EU inspector and an export customer alike.
05Audit, compliance & regulatory support
Readiness held as a condition of the site, not assembled in the three weeks before a visit.
06Performance, MIS & digital systems
Indicators, dashboards and electronic QMS that show the condition of the plant while it can still be influenced.
Products & dosage forms
Expertise in detail Written for the form in front of it
A validation package for an ampoule line has little in common with one written for a tablet block, and a layout that suits dry powder will fail an emulsion.
- API & intermediates Active pharmaceutical ingredients
- Oral solids Solid oral dosage
- Oral liquids Liquid oral dosage
- SVP — up to 100 ml Small volume parenterals
- LVP — above 100 ml Large volume parenterals
- Complex injectables Emulsions & specialised sterile
- Primary packaging Container & delivery systems
Inspection & audit reach
Fifteen authorities, faced from inside the site
Facility inspections faced and supported in quality leadership roles, together with customer, institutional and third-party audits across sterile and non-sterile operations.
- USFDA United States
- EU-GMP Europe
- MHRA United Kingdom
- TGA Australia
- WHO Geneva
- ANVISA Brazil
- INVIMA Colombia
- NDA Uganda
- PPB Kenya
- TFDA Tanzania
- EFDA Ethiopia
- FDA Ghana
- MOH Congo
- NSDO Lesotho
- State FDCA India
How an assignment runs
How we work Assess, report, plan, implement, verify
- 01
Assess
A walk through the plant, an examination of records against what the rooms and equipment actually show, and a direct discussion with the department heads. The position is stated plainly before we leave the site, not weeks later in a document.
- 02
Report
A clause-wise gap register against the standard that will actually be applied, each observation ranked by risk, with photographic evidence where a description would not carry the point.
- 03
Plan
A bridging roadmap separating what must be corrected to remain licensed from what should follow and what can reasonably wait — with layout revisions, sequence, internal owners and target dates identified.
- 04
Implement
Documents drafted, layouts revised, qualification and validation executed, and your people trained alongside the work rather than after it, so the system is understood by those who must defend it.
- 05
Verify
A full mock inspection before the regulator or the customer arrives, followed by support in drafting responses and closing observations to the satisfaction of the authority.
The principal
Himansu Khandhedia, M.Sc. (Chemistry)
Twenty years spanning quality assurance and quality control, production and projects, and distribution and operations — from QA Officer to Site Head – Quality Assurance, Deputy and Assistant General Manager – Quality Assurance, and operational leadership at Chief Operating Officer level.
Layouts designed and taken through approval, quality systems built from the apex documents down, inspections faced from more than fifteen regulatory agencies, and budgets and investment decisions owned rather than recommended.
Insights
All insights Notes from the field
Sterile Manufacturing
Your media fill is only as good as its worst-case rationale
A passed media fill proves very little if the simulation was easier than the process it represents. What the justification has to establish.
Quality SystemsWriting a CAPA that actually closes
Most rejected CAPA responses fail for the same three reasons. None of them is the corrective action itself.
RegulatoryRevised Schedule M: where sites actually fail
The gaps that show up repeatedly are rarely the ones sites budget for. A look at what separates a passed inspection from a deferred one.
The first step
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.