Batch and process records
Which records are kept for each batch and how they can be shared with you.
Manufacturing capabilities
Planned around a documented brief.
How we approach pharmaceutical and nutraceutical manufacturing conversations, and the information that needs to be in place before production is planned.
- Requirements
- Feasibility
- Production planning
- Manufacturing
- Quality review
- Dispatch
Manufacturing philosophy
Agree the brief, then make the product.
Good manufacturing outcomes depend on decisions taken before production begins: what exactly is being made, to what specification, with which materials and with what records.
We therefore put discussion and documentation ahead of promises about output. We do not publish batch sizes, volumes, equipment details or capacity on this website. Those are discussed directly, and only once confirmed.
Environmental-control and HVAC arrangements, and any related classification or qualification documentation, are likewise discussed directly with prospective partners and are not described here until confirmed.
Batch sizesVolumesEquipmentCapacityHVAC & classification
Discussed directly with each prospective partner — not published here.
Product-format categories
Dosage forms of interest.
Choose a format to see the points that usually need defining — and a general, illustrative sequence of how such products are commonly made.
Tablets
Compressed solid oral dosage forms. A clear brief avoids avoidable rework.
Typically defined in the brief
- Intended tablet type and any coating requirement
- Reference specification — pharmacopoeial or in-house, if applicable
- Size, shape and identification expectations
- Pack format: strip, blister or bottle
- Documentation expected with each batch
A general sequence illustrative
- 1Dispensing of materials
- 2Blending / granulation
- 3Compression
- 4Coating (if required)
- 5Inspection & packing
Capsules
Suited to certain powders and granules, with their own considerations on shell, fill and packaging.
Typically defined in the brief
- Preferred shell material — gelatin or plant-based
- Fill type and target fill specification
- Colour, size and printing or identification needs
- Pack format and labelling requirements
- Ingredient and raw-material documentation
A general sequence illustrative
- 1Dispensing of materials
- 2Blending
- 3Encapsulation
- 4Inspection
- 5Packing & labelling
Powder formulations
Blended powders where uniformity, handling and presentation are agreed up front.
Typically defined in the brief
- Formulation brief and ingredient list
- Blend and handling expectations
- Presentation: sachets, pouches or jars
- Flavour or reconstitution considerations
- Label and batch information requirements
A general sequence illustrative
- 1Dispensing of materials
- 2Blending
- 3Sifting (if required)
- 4Filling
- 5Sealing & labelling
Nutraceutical formulations
Wellness-oriented products, where regulatory category and label statements must be clear.
Typically defined in the brief
- Product concept and target dosage form
- Ingredient list and supplier documentation
- Regulatory category you are working under
- Label content and permitted statements
- Shelf-life and storage expectations
A general sequence illustrative
- 1Concept & brief
- 2Ingredient documentation
- 3Dosage-form route
- 4Label review
- 5Packing
Botanical formulations
Plant-based products add questions of identity, sourcing and consistency of the plant material.
Typically defined in the brief
- Botanical raw materials and form required
- Identity and specification documentation
- Sourcing and supply-chain records
- Testing expectations to be agreed
- Presentation format and label content
A general sequence illustrative
- 1Raw-material identity
- 2Defined plant-material form
- 3Blending / formulation
- 4Dosage-form step
- 5Packing
The sequences shown are general and illustrative of how such products are commonly made. They are not a verified description of the company’s operating procedures. Product formats, scope and compliance details are confirmed with each prospective partner.
Potential workflow
An illustrative manufacturing & packaging workflow.
This diagram is illustrative. It shows how a collaboration could be structured and is not a verified description of the company’s operating procedures.
- 1
Requirements
Product, format and expectations are captured in a brief.
- 2
Feasibility
Technical and process review of what is being asked.
- 3
Production planning
Materials, schedule, responsibilities and documents are planned.
- 4
Manufacturing
Production is executed to the agreed process.
- 5
Quality review
Results and records are reviewed against agreed specifications.
- 6
Dispatch
Release, dispatch and a business follow-up.
Packaging and labelling responsibilities, including who supplies and approves each component, are agreed during production planning.
Facility & infrastructure
The premises.
Process & documentation
Records are part of the product.
Which documents accompany a batch, and how long they are kept, should be decided with you rather than assumed.
Material traceability
How incoming materials can be linked to the batches they were used in.
Specifications and test records
Agreed specifications, and the records that show they were checked.
Change control
How changes to a product, process or component are proposed, assessed and approved.
Plain-language glossary
Manufacturing terms, explained.
General definitions to help you prepare for a technical conversation. Exact practice is confirmed per project.
Batch
A defined quantity of product made in one cycle of a process, identified by a batch number.
Specification
The agreed list of tests, limits and requirements a material or product must meet.
Batch record
The document that records how a specific batch was made, with what, and by whom.
Traceability
The ability to link materials, processes and results to a specific batch — forwards and backwards.
In-process check
A check made during manufacture, before the product is finished, to confirm the process is on track.
Certificate of analysis
A document reporting test results for a material or batch against its specification.
Change control
A defined way to propose, assess and approve changes to a product, process or component.
Stability
How a product holds up over time under defined storage conditions — informing shelf-life.
Technical enquiry
Discuss a manufacturing requirement.
Describe your product category and what you need to understand about manufacturing. We will respond with what can be discussed and what needs to be confirmed.
Please do not include confidential formulas, supplier lists or proprietary data. These can be exchanged later under appropriate agreement.
Next step
Looking for a manufacturing partner?
Start a conversation about your product requirements, formulation category and potential manufacturing collaboration. We reply with what can be discussed and what must be confirmed.