Contract manufacturing and development for partner companies

Contract manufacturing

Sterile injectables are filled as oil solutions into 1 ml Type I amber or transparent glass ampoules in Grade A under a Grade B background, flame-sealed, 100% leak-tested and inspected. Oral solids run a granulation, compression and coating train in classified areas, then blister or bulk filling. Both streams end at the same packaging line, so a partner's product leaves with the same batch record, in-process controls and serialised carton as our own register.

Division of responsibility

Active substance & source

Client — with an open or supplied DMF/CEP reference

Formulation & specification

Client, or developed jointly with Ergopharm

Excipients & primary packaging

Ergopharm sourcing, or client-nominated and qualified

Artwork content & market text

Client (approved text); Ergopharm prepares and controls the artwork

Manufacture, packing & serialisation

Ergopharm

In-process, release & stability testing

Ergopharm QC laboratory

Batch record, CoA & retained samples

Ergopharm

Marketing authorisation & pharmacovigilance

Client

Development and technology transfer

A process arriving from a client is not simply copied onto our equipment. We start from the sending unit's documentation — formula, batch record, specifications, methods and any development history — and run a gap analysis against our facility, equipment train and utilities. Feasibility and engineering batches confirm the process behaves as described at our scale before any validation commitment is made.

Technology transfer and validation

1. 01

   Documentation review & gap analysis

   Sending-unit package assessed against our equipment, utilities, materials and analytical capability; differences and risks recorded in a transfer protocol (ICH Q9 risk assessment, ICH Q10 change management).

2. 02

   Feasibility batch

   A small-scale batch confirms compatibility of the formulation with our process train — filtration and fill behaviour for oil solutions, or granulation and compression behaviour for solids.

3. 03

   Engineering batches

   At or near commercial scale, run to establish operating ranges, in-process limits and line settings. Not for commercial supply.

4. 04

   Scale-up

   Parameters translated to the commercial batch size, with the critical process parameters and critical quality attributes fixed in the master batch record.

5. 05

   Analytical method transfer

   Client methods transferred and verified in our laboratory by comparative testing against pre-agreed acceptance criteria, or re-validated to ICH Q2(R2) where the method is amended.

6. 06

   Process validation

   Run to the three-stage lifecycle: Stage 1 process design, Stage 2 process qualification (typically three consecutive PPQ batches), Stage 3 continued process verification on routine production.

Analytical services

• Method development and validation to ICH Q2(R2) — specificity, accuracy, precision, range, linearity, detection and quantitation limits, robustness.
• Method transfer and verification for compendial procedures used under our conditions (USP, Ph. Eur.).
• Stability studies to ICH Q1A(R2): long-term, intermediate and accelerated, with zone-matched storage for the destination market.
• Photostability to ICH Q1B and forced-degradation studies to establish stability-indicating capability.
• Release testing against the finished-product specification — identification, assay, related substances, uniformity of dosage units, dissolution or disintegration.
• Sterile-product testing: sterility (USP <71>), bacterial endotoxins (USP <85>), particulate matter (USP <788>).
• Impurity and residual-solvent profiling to ICH Q3A / Q3B and Q3C; elemental impurities to ICH Q3D.
• Out-of-specification investigation, trending and periodic product quality review support.

Stability storage conditions (ICH Q1A(R2))

Long-term — zones I / II

25 °C ± 2 °C / 60% RH ± 5%

Long-term — zone IVa

30 °C ± 2 °C / 65% RH ± 5%

Long-term — zone IVb

30 °C ± 2 °C / 75% RH ± 5%

Intermediate

30 °C ± 2 °C / 65% RH ± 5%

Accelerated

40 °C ± 2 °C / 75% RH ± 5%

Pull points

0, 3, 6, 9, 12, 18, 24, 36 months long-term; 0, 3, 6 accelerated

Chambers

Mapped, continuously monitored and alarmed

Packaging and serialisation as a service

Artwork management

Origination, version control and change history against approved client text

Market-specific labelling

Language variants, local pictograms, prescription statements and pack text per destination

Carton coding

GS1 DataMatrix ECC200 — (01) GTIN, (17) expiry, (10) batch, (21) serial, plus the human-readable line

Code quality

Every mark read and graded in line by vision system; unreadable codes rejected

Tamper-evidence

Anti-tampering device applied and verified on the outer carton

Commissioning

Serial numbers commissioned and reconciled per batch (printed / passed / rejected / aggregated)

Aggregation

SGTIN pack to SSCC case to SSCC pallet, as EPCIS parent–child events

Data exchange

EPCIS 2.0 files, or connection to the client's repository or traceability provider

Serial number source

Client-supplied ranges under the client's GS1 company prefix, or generated to an agreed scheme

How an engagement runs

1. 01

   Enquiry and confidentiality agreement

   You describe the product, dosage form, volumes and destination markets. A mutual non-disclosure agreement is signed before any technical package is exchanged.

2. 02

   Technical feasibility

   We review the formulation, process and analytical package against our equipment, materials and capacity, and return a written feasibility position with the gaps and risks named.

3. 03

   Quotation and quality agreement

   Commercial terms, batch sizes and lead times are quoted alongside a written quality agreement defining GMP responsibilities, release, deviation handling, change control and audit rights on both sides.

4. 04

   Technology transfer

   The transfer protocol is executed — documentation, materials qualification, method transfer and equipment readiness — with defined acceptance criteria at each step.

5. 05

   Engineering and validation batches

   Engineering batches establish the settings; process performance qualification batches confirm reproducibility. Stability is placed on validation batches to support the client's filing.

6. 06

   Commercial supply

   Routine manufacture against a rolling forecast, with continued process verification, periodic product quality review and serialised, aggregated consignments shipped under GDP.

What we ask from a prospective client

• Evidence that you are a licensed pharmaceutical company, or that you hold or are filing a marketing authorisation in the destination market.
• The product's dosage form, strength, presentation and target markets, with expected annual volumes and a forecast horizon.
• A technical package: formulation and composition, manufacturing process description, in-process and finished-product specifications, analytical methods with validation reports, and any existing stability data.
• Active-substance source and quality documentation — a DMF, CEP or equivalent — with an agreed supplier and a qualification route.
• Approved artwork text and any market-specific labelling requirements.
• Your traceability scheme and repository if the market requires serialised reporting, plus GS1 identifiers where serials are to be issued under your prefix.
• A named quality contact and a named technical contact, and willingness to sign a quality agreement and accept an audit relationship.

What we will not do

• We do not manufacture or pack product for direct-to-consumer supply. Finished goods are released only to licensed companies, distributors and importers.
• We do not supply unlicensed intermediaries, individuals, or any party that cannot evidence its authorisation to handle prescription medicines in the destination market.
• We do not accept work that would require Ergopharm to state or imply a regulatory approval, certification or prequalification it does not hold. We describe our own facility and processes and reference published standards; we do not borrow anyone else's approval.
• We do not label or present a product in a way that misstates its origin, its manufacturer or its prescription status.
• We do not take on products outside the two streams we operate — sterile oil-solution ampoules and oral solid dose — or outside our licensed material scope.
• We do not release a batch without a completed, reviewed batch record and passing release testing, whatever the delivery date.

Capability envelope (illustrative)

Dosage forms

Sterile oil-solution injectable; film-coated and uncoated oral tablets

Sterile container

1 ml Type I amber or transparent glass ampoule, flame-sealed

Sterile secondary pack

10 ampoules per carton, serialised; case and pallet aggregated

Oral solid formats

Blister and bulk, 10–100 count per pack

Sterile batch size

50,000 – 1,000,000 ampoules per batch

Oral solid batch size

100,000 – 500,000 tablets per batch

Annual capacity

Up to 200 million ampoules and 10 million tablets

Minimum order — injectable

From 100,000 ampoules (10,000 cartons) per presentation

Minimum order — oral solid

From 200,000 tablets per presentation

Feasibility response

4–6 weeks from a complete technical package

Technology transfer

3–6 months to the first engineering batch, process dependent

Validation programme

Typically 3 consecutive PPQ batches, 8–12 weeks

Commercial lead time

8–12 weeks from firm order; 12–16 weeks where new artwork or serial ranges apply

Stability programme

Up to 36 months long-term, zone-matched to the destination market