Introduction
These guide?lines are intended to provide guidance regarding Good Manufacturing Practices for
cosmetic products. These guidelines have been prepared for consideration by the cosmetic
industry and take into account the specific needs of this sector. These guidelines offer
organi...更多Introduction
These guide?lines are intended to provide guidance regarding Good Manufacturing Practices for
cosmetic products. These guidelines have been prepared for consideration by the cosmetic
industry and take into account the specific needs of this sector. These guidelines offer
organizational and practical advice on the management of the human, technical and administrative
factors affecting product quality.
These guidelines have been written to allow them to be used following the flow of products from
receipt to shipment. Additionally, in order to clarify the way this document reaches its objectives, a
‘principle’ is added to each major section.
Good Manufacturing Practices constitute the practical development of the quality assurance
concept through the descrtption of the plant activities that are based on sound scientific judgement
and risk assessments. The objective of these GMP guidelines is to define the activities that enable
you to obtain a product that meets defined characteristics.
Documentation is an integral part of Good Manufacturing Practices.
介 紹
這份準(zhǔn)則為化妝品良好生產(chǎn)規(guī)范做出指導(dǎo)，是適合化妝品行業(yè)并考慮了行業(yè)的具體要求，在人
員，技術(shù)和影響產(chǎn)品質(zhì)量的綜合因素方面提供了系統(tǒng)性的和實(shí)際性的建議。
這個(gè)指導(dǎo)是為了讓員工遵守產(chǎn)品接收到裝運(yùn)的流程下如何去利用資源。為了達(dá)到此目的，在每
一個(gè)章節(jié)里都添加了“原則”這一欄。
良好生產(chǎn)規(guī)范中的質(zhì)量保證發(fā)展觀念是通過描述建立在科學(xué)有效的判定和風(fēng)險(xiǎn)評(píng)估上的工廠活
動(dòng)來完成的，這份準(zhǔn)則的目的是為了界定能讓你獲得達(dá)標(biāo)產(chǎn)品的活動(dòng)。
文件是 GMP 不可或缺的一部分。
4
ISO22716:2007(E)
化妝品良好生產(chǎn)規(guī)范準(zhǔn)則
1 Scope 范圍
This International Standard gives guidelines for the production, control, storage and shipment of cosmetic products
此國(guó)際標(biāo)準(zhǔn)為化妝品生產(chǎn)，控制，儲(chǔ)存和裝運(yùn)提供指南
These guidelines cover the quality aspects of the product, but as a whole do not cover safety aspects for the personnel
engaged in the plant, nor do they cover aspects of protection of the environment. Safety and environmental aspects are
inherent responsibilities of the company and could be governed by local legislation and regulation.
這個(gè)標(biāo)準(zhǔn)包含產(chǎn)品質(zhì)量的各個(gè)方面但不包括員工安全和對(duì)環(huán)境的保護(hù)方面，安全和環(huán)境保護(hù)是公司的應(yīng)的責(zé)任，可
以通過當(dāng)?shù)氐姆珊头ㄒ?guī)加以管制
These guidelines are not applicable to research and development activities and distribution of finished products.
這些準(zhǔn)則并不適用于設(shè)計(jì)和開發(fā)和產(chǎn)品營(yíng)銷活動(dòng)。
2 Terms and definitions 術(shù)語和定義
For the purposes of this document, the following terms and definitions apply.
以下術(shù)語和定義對(duì)于本文件是適用的
2.1 acceptance criteria 接收標(biāo)準(zhǔn)
numerical limits, ranges, or other suitable measures for acceptance of test results
數(shù)值限度，范圍或者其他可作為接受測(cè)試結(jié)果的方法
2.2 audit 審核
systematic and independent examination to determine whether quality activities and related results comply with planned
arrangements and whether these arrangements are implemented effectively and are suitable for achieving objectives
為獲得審核證據(jù)并對(duì)其進(jìn)行客觀評(píng)價(jià)，以確定滿足審核準(zhǔn)則的程度而進(jìn)行的 系統(tǒng)的、獨(dú)立的、形成文件的過程。
2.3 Batch 批
defined quantity of raw material, packaging material or product issued from one process or series of processes so that it
could be expected to be homogeneous
從某個(gè)或多個(gè)操作獲得的、認(rèn)為是一致的特定數(shù)量的原料，包材或產(chǎn)品。
2.4 batch number 批號(hào)
distinctive combination of numbers, letters and/or symbols, which specifically identifies a batch
單個(gè)數(shù)字，字母，或字母和數(shù)字結(jié)合的，用來指定識(shí)別一批產(chǎn)品的代碼.
2.5bulk produc 散裝產(chǎn)品
any product which has completed manufacturing stages up to, but not including, final packaging
經(jīng)過所有制造工藝過程的產(chǎn)品，除了沒有填充到獨(dú)立包裝的產(chǎn)品。
2.6Calibration 校準(zhǔn)
set of operations that establish, under specified conditions, the relationship between values indicated by a measuring
5
6
instrument or measuring system, or values represented by a material measure, and the corresponding known values of a
reference standard
在特定條件下，通過一系列操作在測(cè)量?jī)x器或測(cè)量系統(tǒng)所指示的量值，或事物量具或參考事物表示的值，和按標(biāo)準(zhǔn)
實(shí)現(xiàn)的相應(yīng)值間建立起一種關(guān)系。
2.7 change control 變更控制
internal organization and responsibilities relative to any planned change of one or several activities covered by the Good
Manufacturing Practices in order to ensure that all the manufactured, packaged, controlled and stored products correspond
to the defined acceptance criteria
為確保生產(chǎn)，包裝，控制，儲(chǔ)存符合接收標(biāo)準(zhǔn)，組織所作的內(nèi)部機(jī)構(gòu)、職責(zé)與 GMP 內(nèi)容有關(guān)的任何計(jì)劃的變動(dòng)。
2.8Cleaning 清洗
all operations that ensure a level of cleanliness and appearance, consisting of separating and eliminating generally visible
dirt from a surface by means of the following combined factors, in variable proportions, such as chemical action,
mechanical action, temperature, duration of application
為確保達(dá)到潔凈水平，隔離或消除表面贓物的所有操作。例如用化學(xué)作用，機(jī)械作用，溫度，時(shí)間等方法。
2.9Complaint 投訴
external information claiming a product does not meet defined acceptance criteria
外部信息斷言成品有質(zhì)量缺陷。
2.10Contamination 接觸污染
occurrence of any undesirable matter such as chemical, physical and/or microbiological matter in the product
指在產(chǎn)品中發(fā)現(xiàn)任何不應(yīng)出現(xiàn)化學(xué)的，物理的，生物的物質(zhì)的事件。
2.11Consumables 耗材
materials such as cleaning agents and lubricants that are used up during cleaning, sanitization ormaintenance operations
指某些在清潔、**或維護(hù)中消耗的材料諸如清潔劑、潤(rùn)滑油等。
2.12contract acceptor 受托方
person, company or external organization carrying out an operation on behalf of another person, company or organization
代表某人、公司、組織實(shí)施操作的個(gè)人、公司或外部的組織。
2.13
Control 控制
verification that acceptance criteria are met 確認(rèn)可接受準(zhǔn)則得到滿足
2.14
Deviation 偏差
internal organization an
