Business Development / Manufacturing Readiness
Manufacturing Readiness
A factory requires facilities, equipment, personnel, a quality system, and business requirements that work together.
The following discussion focuses on cosmetics manufacturing. Home care products require technical assessment and the regulatory pathway appropriate to their classification.
Facilities, Personnel, and Production Systems
Buildings and machinery need competent personnel, quality systems, documentation, and compliance with business and product requirements.
Complexity comes from connected decisions: dosage forms affect equipment and facilities; capacity affects investment; testing and documentation affect product readiness.
The following details concern cosmetics manufacturing. Home care products require their own classification and compliance pathway.
01Business identity & risk-based licensingView details
NIB and appropriate business activities
Define the legal entity, business identification number (NIB), activity classification, location, and scale through OSS. Additional requirements depend on risk level and the selected activities. NIB identifies the business; it does not replace all production requirements.
Scope of activities, business documents, and consistency of project information.
02Location, environment & buildingsView details
Spatial planning, environment, PBG and SLF, as applicable
Assess site suitability, environmental obligations, and requirements for buildings and their use. The applicable requirements depend on the project, scale, location, and prevailing rules.
Land or rental costs, design, construction, environmental management, and building safety.
03Facilities & utilitiesView details
Production flows and operating conditions
Prepare personnel and material flows, storage, processing and packaging areas, process water, sanitation, and environmental controls appropriate to the products and CPKB requirements.
Contamination prevention, utility maintenance, cleanliness, and sufficient capacity.
04Technical personnel & organizationView details
Qualified technical leadership and personnel
Provide the technical person responsible according to the industry category: a pharmacist for Category A, and the required pharmaceutical technical personnel for Category B. Check permitted dosage forms and industry criteria before planning the facility.
Recruitment, training, allocation of responsibilities, and competence records.
05Quality system & CPKBView details
Implementation that can be inspected
Prepare the quality system, procedures, production records, quality control, storage, complaints, and product recalls. Certification follows BPOM Regulation 8/2026 and the facility's scope.
Inspection readiness, corrective actions, change control, and ongoing compliance.
06Equipment & process readinessView details
Equipment must suit the process and product
Select equipment according to dosage form, capacity, cleaning needs, and ability to deliver consistent quality. Process plans should cover measurement, maintenance, and scale-up evaluation.
Equipment investment, maintenance, calibration where required, downtime, and production losses.
07Materials, testing & product documentationView details
Material quality and readiness of each formula
Manage suppliers, material and packaging specifications, necessary stability and compatibility evaluations, quality testing, and product information documents as required for each product.
Material traceability, formula conformity, test results, and product release decisions.
08Operations & working capitalView details
Responsibilities continue after the facility is ready
Plan people, energy, testing, maintenance, inventory, waste, distribution, and changes in demand. Unused capacity and unsold goods still require cost and cash management.
Fixed costs, inventory, workplace safety, productivity, complaints, and funding requirements.
Under BPOM Regulation 8/2026, BPOM states that holders of a Certificate of Compliance with Aspects of CPKB may not accept contract production. For contract manufacturing, check the CPKB certificate, permitted dosage forms, and current status under the applicable rules.
The facility must meet its requirements.
Each product must also be prepared.
Business licensing, site and buildings, technical personnel, and CPKB certification and implementation for the relevant scope.
Formulas and specifications, product documentation, BPOM notification before distribution, labels and claims, and applicable halal requirements.
Facility certification does not automatically provide notification numbers for every product. Each party's status, scope, and responsibilities need to be defined.
Brand owners still need to agree specifications, contractual rights and obligations, responsibility for notification, product information, sales, customer service, and complaint handling with the manufacturer. Responsibilities should be clear from the outset.
Official references & compliance notes
This educational summary was reviewed on 15 October 2026. Requirements and processes depend on the activities, location, scale, dosage forms, and current regulations. This is not an identical licensing checklist for every project.