Duty plan for contract manufacturers

Active substance concepts: aims, competence, availability

Testing of so called mutual chemistry

Capacity demand, forecast availability for bulk, bottling

Matching company sizes

Timeplan for introduction

Time required for  implementation, testing, documentations

Clarification of cooperation time (succession policies)

Agreement on communication ways (phone, fax, e-mail …)

Introduction of professional competence

Certificate of GMP of cosmetics

Availability of official permits

Proof of production capacity

Proof of bottling capacity

Visit of raw material stock

Portraying of raw material orders and delivery times for raw materials

Resulting minimum purchase volume, influence on delivery times

Documentation of technical potential

Documentation of bottling technology

QA description, measurable QC-measuring parameters

Extent of common QC data (including external measurement)

Standard values (measurement data, Knowledge-based-Engineering,) for a finished product

Agreement on desired raw material specifications (spec, GMO, KBE)

Way of communication with decision makers (e-mail, phone, fax …)

Agreement on persons who are responsible

Way of documentation, archiving method, capacity

Normal pattern for starting from a product idea to first delivery, time required

Time required developing phase

Time required until production maturity, tests, scale-up

Time required until market maturity / legal marketability

Standard logistics for samples and production batches, pickup agreements

Agreement on responsible person’s (rP) function / – interfaces

Delegation of duties (project wise, exclusive…)

Determination of decision makers and decision-making procedures (lifting  of control)

Confidentiality agreement with third parties (SHB, consultants …)

Exclusivity agreement for written forms (development, agreements)

Conflicts caused by agreements with competitors

Agreement to customers’ principles (QA, delivery conditions …)

Agreements for substitution, succession

Disclosure of association to other corporate enterprises

Warehousing of raw materials and packings

To be ready for audits and certifications

Business interruption: closed for holiday, public holiday

Quality standard, price class

Depth of documentation at customers and production manufacturer

Persons with instruction competence

Project plan (time..) for planned introduction on the market

Planning of customer audits during co-operation

Responsible decision maker

Delivery control: measurement parameters, QC-system requirements

Handling and filling device when buying in bulk amounts

Providing appropriate documentation

Analysis certificate for delivery way

Disclosure of recipe, selling of recipe, recipe residual value after termination

Additional customer QC before production dispatch: samples, analysis, deadline

Time of receiving goods

Packing briefing

Legal scope (EU, USA, Japan, Korea…)

Export requirements

Customer blacklist (by customer forbidden substances)

Standards: Natural, functional cosmetic,…

(Tolerances): raw material type and amount, HV, fill-up quantity

Instruction for usage of customer raw materials

Marketing objective: target group, target markets

Batch size

Tolerances: auxiliary materials, contamination

SOP-Testing method for samples: type, timing

Light stability

Packing compatibility

Packing functionality

Physical product functionality

BBD-, PAO regulation

Organoleptic, look-and-feel, consumer acceptance

Physiological effectiveness

SPF

Microbiological stability test (if necessary)

Patch test

Chemical analysis of active components, sensitive components, contamination

Approval: specification, feel, sample no.

Agree in writing with measurement parameters for product specifications

Approval in written protocol (code, labelling, PID-instructions)

Binding agreement in documentation on product name

Specification, raw material test / approval (quality, quantity, MB)

List of items: packing, display

Packing test: quality, quantity, MB, print, analytics

Multi-packs / partitions for tubes, display packing …

Ram material documents (including article 19ii): SDB, INCI

Packing conformity certificate, proof of migration

Forecast, production scheduling

Product calculation, expenditure calculation, written offer with terms and conditions

Raw material: acquisition / supply / storage

Defining and setting up device for production

Packing: acquisition / supply / storage

Assessment for bulk specification

Agreement on QC-measurement data: pC, MB, touch-and-feel

Approval procedure SOP (QKB, sample, approval form, deadline for approval)

Specification of approval on customers side (disclosure customer SOP)

Approval of acceptance: deadline, communication way

Objections SOP (objection deadline, conditions for revision …)

Disclosure of customer procedure of further processing, technical facilities

RSM: bulk, finished packed items

Labelling test

SDB of product when containing dangerous substances (applies only for bulk)

Analysis of product test, internal approval for production