What we build, and what it is built against
Six areas of work, scoped to the situation in front of them — a single audit response, a Revised Schedule M transition, a new block taken from drawing to qualification, or continuing quality oversight.
Plant layout, projects & regulatory approvals
A layout decides how much compliance will cost for the next twenty years. Rooms in the wrong sequence, a corridor doing two jobs, or a utility routed through a clean area cannot be corrected later by procedure — they are paid for in every batch, every deviation and every inspection that follows. We design layouts against the regulation that will judge them, for new facilities and for plants being reworked inside walls that already exist.
- Greenfield plant, block and production line layout design
- Brownfield restructuring within an existing building envelope
- Man, material, waste and personnel flow design
- Area classification, pressure cascade and airlock strategy
- Segregation, containment and cross-contamination control
- Utility routing and capacity planning — HVAC, water, gases
- Drawings and submission support for FDCA layout approval
- Project risk assessment and mitigation planning
- Equipment selection, user requirements and vendor evaluation
- Installation, commissioning and qualification coordination
- Technology transfer between sites and to contract manufacturers
- New-product project coordination for regulated markets
Total quality management system
A quality system is not a shelf of files. It is a small number of apex documents stating what the organisation stands for, and a set of working procedures that make those statements true every day. We build both — beginning with the Quality Policy, Quality Manual, Site Master File and Validation Master Plan, then the operating elements beneath them, then the SOP architecture and the training that puts it into the hands of the people who run the plant.
- Apex documents — Quality Policy, Quality Manual, Site Master File, Validation Master Plan
- Change control and change management
- Deviation and incident management
- OOS and OOT investigation with structured root cause analysis
- CAPA management and effectiveness verification
- Market complaint, product return and recall procedure
- Quality risk management and site risk registers (ICH Q9)
- Self-inspection and internal audit programme
- Product Quality Review / APQR and management review
- Vendor qualification and approved vendor management
- Batch record review, release and retained sample control
- SOP architecture — hierarchy, drafting, roll-out and revision
- Training and competency development, delivered on the floor
- Data integrity governance (ALCOA+) and audit trail review
Qualification & validation
Most sites are found wanting here not because the work was never done, but because the file does not prove it. We take the lifecycle from user requirement to periodic review, writing protocols that can be executed by the people who have to execute them, and reports that stand on their own when an inspector reads them three years later.
- URS, DQ, FAT, SAT, IQ, OQ and PQ across the equipment lifecycle
- Facility and cleanroom qualification
- Utility qualification — HVAC, purified water, WFI, pure steam, compressed gases
- Process validation and continued process verification
- Cleaning validation, MACO rationale, recovery and hold-time studies
- Analytical method validation, verification and transfer
- Stability programme design, protocols, chambers and trend evaluation
- Computerised system validation and electronic record controls
- Environmental monitoring programme and qualification of clean areas
- Granulation, blending and compression process validation — blend and content uniformity
- Coating process validation and film consistency
- Dissolution method development, validation and profile comparison
- Hold-time and in-process stability for bulk granules, cores and solutions
- Preservative efficacy and antimicrobial effectiveness studies
- Microbial limits and water quality control for non-sterile products
- Media fill / aseptic process simulation for sterile operations
- Re-qualification, periodic review and validation status maintenance
- Validation Master Plan ownership and schedule governance
GMP documentation — the complete library
An inspector does not assess intention; he reads documents. The documentation below is what we develop, restructure or independently review — written to be consistent with one another, so that a single set satisfies the State licensing authority, a WHO or EU inspector and an export customer, rather than three parallel sets being maintained by a team that has no time to maintain even one.
Audit, compliance & regulatory support
Audit readiness is a condition, not a project undertaken three weeks before a visit. The objective is a site where the answer to an inspector’s question is already on the shelf, and where the people who must speak to it have done so before.
- Pre-audit gap assessment against the applicable standard
- Mock inspection with front-room and back-room discipline
- Preparation and rehearsal of subject-matter experts
- Document and data readiness review ahead of inspection
- Observation response drafting, CAPA and closure to the agency
- Hosting of regulatory, customer and third-party audits
- Excipient and active ingredient supplier qualification audits
- Testing laboratory, calibration and validation service provider audits
- Packaging material and sterilisation service provider audits
- Contract manufacturer and loan-licence site audits
- Technology transfer — process, method, documentation and first batches
- ICH Q7 gap assessment for active pharmaceutical ingredient manufacture
- Good Distribution Practice and temperature mapping across the chain
- Technical and quality agreements with contract sites
- Oversight of outsourced product quality and release
- Quality inputs for CTD Module 3 and dossier submission
- Support for WHO-GMP, COPP and market registration needs
Performance, MIS & digital systems
Most plants discover their condition only after something has gone wrong. Defined indicators, honestly reported, turn quality from an argument into a measurement — and give management a view of the plant while there is still time to influence it.
- Quality indicator definition, baselines and review cadence
- Deviation, OOS, complaint and recall trend analysis
- Batch right-first-time, rejection and rework monitoring
- CAPA ageing and effectiveness tracking
- Training compliance and competency measurement
- Management information system for plant-health reporting
- Dashboards for management and board-level review
- Electronic QMS selection, roll-out and migration from manual systems
- Computerised system validation of implemented software
- Customised software developed for organisation-specific needs
- Process improvement and productivity initiatives
- Automation and digital transformation of routine documentation
The full list
43 services across 7 areas. The sections above set out the work we are asked for most often; this is everything, including the pieces that are usually part of a larger engagement.
Projects & facility
- Plant layout design & regulatory approval FDCA and CDSCO submissions, drawings through to approval.
- Greenfield & brownfield project consultancy A new block or plant, from concept to commissioning.
- Cleanroom design & classification review Grades, personnel and material flow, pressure cascade, containment.
- Utility design review HVAC, purified water and WFI, compressed gases.
- Equipment selection & vendor evaluation Specification, user requirements, technical comparison.
- Commissioning & first-batch readiness Sequencing qualification against a committed start date.
Qualification & validation
- Granulation, blending & compression validation Blend and content uniformity, compression and coating consistency.
- Dissolution method development & validation Method, validation and profile comparison for oral solids.
- Hold-time and in-process stability studies Bulk granules, cores and solutions, held and proven.
- Preservative efficacy & microbial limits Antimicrobial effectiveness and water control for non-sterile products.
- ICH Q7 gap assessment for active ingredients API manufacture assessed against the standard written for it.
- Validation Master Plan Site validation strategy and sequencing.
- Equipment, facility & utility qualification DQ, IQ, OQ, PQ and periodic requalification.
- Process validation Prospective, concurrent and continued process verification.
- Cleaning validation Worst case selection, MACO, health-based limits, recovery.
- Media fill design & rationale Intervention matrix and worst-case justification.
- Sterilisation & depyrogenation cycle validation Moist heat, dry heat and filtration.
- Analytical method validation & transfer Between laboratories, sites or contract partners.
- Computerised system validation CSV and the risk-based CSA approach.
Compliance & inspection
- Contamination control strategy — non-sterile The document Schedule M expects, written for a non-sterile plant.
- Good Distribution Practice & temperature mapping Storage, transport and the records that prove the chain held.
- Revised Schedule M gap assessment Clause by clause, with a costed remediation roadmap.
- Mock inspection & audit readiness CDSCO, State FDA, WHO-GMP, EU-GMP, US FDA and PIC/S.
- Observation and Form 483 response Root cause, CAPA plan and closure evidence.
- Customer and vendor audit support Hosting the audit, and answering what follows.
- Self-inspection programme design So the site finds its own gaps between audits.
- Data integrity assessment ALCOA+ across instruments, logbooks and spreadsheets.
Audit & oversight
- Excipient and API supplier qualification audit A defined scope, an audit at their site, and a report you can act on.
- Laboratory and calibration provider audit Contract testing, calibration and validation service providers.
- Contract manufacturing site qualification & oversight Loan-licence and third-party sites, from qualification to release.
- Technology transfer Process, method, documentation and first batches to steady state.
- Technical and quality agreements What each side owes the other, written before it is needed.
Quality systems & documentation
- Quality management system build or rebuild SOP architecture, ownership and review cycle.
- Deviation, OOS and CAPA framework Investigations that reach a real root cause.
- GMP documentation development BMR, BPR, specifications, protocols and formats.
- Annual product quality review Design, trending and management review.
- Quality risk management FMEA applied to product, process and facility.
- Change control system Regulatory impact assessed before the change is made.
- Vendor qualification & quality agreements Including loan-licence oversight.
Market access & registration
- Site Master File Written and maintained.
People & performance
- Quality metrics, MIS & digital systems Indicators that are actually used.
- GMP and aseptic behaviour training With effectiveness assessed, not just attendance.
- Data integrity & documentation practice training For operators, QA and QC.
Delivered on the floor, in the language the floor works in
Every assignment includes training, because a system nobody understands is a system that decays the moment the consultant leaves. Sessions are run for the people who will use what has been built — operators, chemists, supervisors and department heads — in English, Hindi or Gujarati, the language the floor actually works in.
Subjects covered
- Revised Schedule M and what it changes in practice
- Data integrity and good documentation practice (ALCOA+)
- Deviation and OOS investigation that reaches a real root cause
- Writing a CAPA that closes
- Cleaning validation rationale, MACO and health-based limits
- Qualification and validation for the people who execute the protocols
- Facing an inspection — front room, back room and how to answer
- Self-inspection that finds things before an auditor does
Standalone training can be arranged where no other work is under way.
Questions we are asked before an engagement starts
What does the Revised Schedule M require a manufacturer to do?
It requires a documented Pharmaceutical Quality System, not just compliant premises. Beyond the upgrades to buildings, utilities and equipment, it expects quality risk management applied to product and process, a product quality review that actually drives action, change control that assesses regulatory impact before a change is made, deviation and CAPA handling that reaches root cause, and computerised systems governed for data integrity. Most sites budget for the capital work and are found short on the system work.
How do I prepare a plant for a WHO-GMP or regulatory inspection?
Run a mock inspection to the format and pace of the real one, then remediate by risk rather than by page count. That means examining what an inspector actually examines — batch records pulled at random, qualification files, deviation trends, training effectiveness — and classifying every gap by patient risk and regulatory exposure. Preparation that starts from a checklist rather than from your own records tends to miss the findings that matter.
What is the difference between qualification and validation?
Qualification proves equipment, facilities and utilities are fit for purpose; validation proves the process using them consistently produces what it should. In practice qualification covers design, installation, operation and performance of an asset — HVAC, water systems, an autoclave, a filling line — while validation covers the manufacturing process, cleaning, and analytical methods. Validation rests on qualification, so a validation study built on an incomplete qualification file will not stand up to review.
How should a site respond to GMP audit observations?
State a root cause that is a system condition, not a restatement of the observation. Responses are rejected most often because the root cause simply repeats the finding in the past tense, because the correction is presented as the corrective action, or because the effectiveness check has no measurable indicator, defined period or pre-stated threshold. Scope also matters: if the cause exists elsewhere on site, the response has to say where it was looked for.
Does Selvinium Solutions work with plants outside Gujarat?
Yes — assignments are taken across India, with periodic site visits and remote support between them. Documentation, protocol drafting and review are carried out off site wherever that can be done properly, so travel is reserved for the work that genuinely needs someone on the floor.
What kind of consultancy does Selvinium Solutions provide?
Pharmaceutical plant projects, GMP compliance and quality systems consultancy, led by Himansu Khandhedia, M.Sc. (Chemistry), from Ankleshwar, Gujarat. The work spans plant layout design and regulatory approvals, Revised Schedule M transition, qualification and validation, quality management systems, GMP documentation, and audit and inspection support — across sterile and non-sterile dosage forms from active ingredients to finished product.
Tell us what is due, and by when.
Most engagements begin with one of four situations: an inspection is scheduled, an observation has landed, a new line or block is being built, or the standard has moved and the current system no longer meets it. Say which one applies and you will get a direct answer on scope, sequence and effort.