PZ Cussons Group GMP Audit v 1.

Section

1.0 Introduction & Index

Introduction This audit pro forma is based on the structure of the International Standards Organisation guideline to GMP - draft document - ISO DIS 22716 The ISO document has passed the review stage has now been published This audit document has a 1 to 5 scoring system to enable assessment of continuous improvement in the GMP area to be monitored 1 Indicates - non compliance, 2,3 & 4 indicate partial and increasing compliance, 5 is fully compliant There are some audit questions which will only be scored either 1 or 5 ie No or Yes Sheet Area No. 1 2 3 4 5 6 7 8 9 10 11 Introduction & Index Terms & Definitions Personnel Premises Equipment Raw Materials & Pkg components Production Finished product Quality Control laboratory Out of specification Product Wastes

PZ Cussons Group GMP Audit v 1.1

Section

2.0 Terms & Definitions

back to '1 Index & Introduction'

2 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

2.1 acceptance criteria

Numerical limits, ranges, or other suitable measures for acceptance of test results.

2.2 audit
A 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 to achieve objectives. batch A 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. batch number A distinctive combination of numbers, letters and/or symbols that specifically identifies a batch. bulk product Any product which has completed processing stages up to, but not including, final packaging. calibration The set of operations which establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or values represented by a material measure, and the corresponding known values of a reference standard. change control 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. cleaning All operations that ensure a level of cleanliness and appearance by means of the following combined factors, in variable proportions: chemical action, mechanical action, temperature, duration of application. It is the action of separating and eliminating generally visible dirt from a surface. complaint External information claiming a product does not meet defined acceptance criteria. contamination The occurrence of any undesirable matter (chemical, physical and/or microbiological) in the product. consumables Consumables are materials that are used up during cleaning or maintenance operations. These can be cleaning agents and lubricants for example. contract acceptor Person, company or external organization carrying out an operation on behalf of another person, company or organization. control Verification that acceptance criteria are met. deviation

2.3 2.4 2.5 2.6

2.7

2.8

2.9 2.10 2.11 2.12 2.13 2.14

Internal organization and responsibilities relative to the authorization to deviate from specified requirements due to a planned or unplanned and, in any case, temporary situation concerning one or several activities covered by the Good Manufacturing Practices. 2.15 finished product A cosmetic product that has undergone all stages of production including packaging in its final container for shipment. 2.16 in-process control Controls performed during production in order to monitor and, if appropriate, to adjust the process to ensure that the product meets the defined acceptance criteria. 2.17 internal audit A systematic and independent examination made by competent personnel inside the company. The aim is to determine whether activities covered by this guideline and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives. 2.18 major equipment Equipment specified in production and laboratory documents that are considered essential to the process. 2.19 maintenance Any periodic or unplanned support and verification operations designed to keep premises and equipment in proper working condition. 2.20 manufacturing operation Set of operations from the weighing of raw materials to the making of the bulk product. 2.21 out-of-specification Examination, measurement or test result that does not comply with defined acceptance criteria. 2.22 packaging operation All packaging steps including filling and labelling which a bulk product has to undergo in order to become a finished product. 2.23 packaging material Any material employed in the packaging of a cosmetic product, excluding any outer packaging used for transportation. Packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product. 2.24 plant The location for production of cosmetic products. 2.25 premises Physical location, buildings and supporting structures used to conduct receipt, storage, manufacturing, packaging and control and shipment of product, raw materials and packaging materials. 2.26 production The manufacturing and packaging operations. 2.27 quality assurance All those planned and systematic activities necessary to provide confidence that a product satisfies given acceptance criteria. 2.28 raw material Any substance going into or involved in the processing of a bulk product. 2.29 recall Decision made by a company to call back a product batch that has been put on the market.

2.30 reprocessing
Re-treatment of all or part of a batch of finished or bulk product of an unacceptable quality from a defined stage of production so that its quality may be rendered acceptable by one or more additional operations. 2.31 return

Sending finished cosmetic products which may or may not present a quality defect back to the plant.

2.32 sample
One or more representative elements selected from a set to obtain information about that set.

2.33 sampling
Set of operations relating to the taking and preparation of samples. 2.34 sanitization Operation, used to reduce undesirable micro-organisms on inert contaminated surfaces depending on the objectives set. It is the action of reducing generally invisible contaminants from a surface. 2.35 shipment Set of operations relative to the preparation of an order and its putting in a transport vehicle. 2.36 waste Any residue of a production operation, transformation or use, any substance, material, product that its holder intends for disposal.

PZ Cussons Group GMP Audit v 1.1

Section

3.0

Personnel
back to '1 Index & Introduction'

ISO Ref

Area

Detail

NonCompliant Rating 1

Partially compliant Rating 2 Rating 3 Rating 4

Fully compliant Rating 5

Comments

3.2

Organisation

Do detailed organisation charts for whole company / sections exist? Is QA / QC independent of production ie report to senior site management not production? Are there sufficient staff within QA QC area? Are all currently shown QA QC posts filled?

Sudah ada nama, sampai dengan supervisor

3.3.1 Management responsibilities

Is there a clear statement within the Quality manual that senior site management endorse and are actively involved in GMP? Is it clear in senior management job descriptions that they have responsibility for GMP? Do intermediate management have GMP responsibilities clearly stated in their job descriptions and objectives Do senior management define and communicate who are authorised personnel?

Ada, tapi implementasi tidak full, tidak urgent

Sudah ada QMR difactory. Dan sudah ada penunjukannya.

3.3.2 Responsibilities of personnel

Do all personnel :- Know their position in the organisational structure - Know their defined responsibilities and activities - Have a formal job description - Have easy access to the relevant documentation necessary for their role - Are they encouraged to report irregularities / non conformities at the level of their role - Have adequate education, training and skills appropriate to their role - Comply with the personal hygiene requirements stated in GMP policy / guidelines Jelas ada SOP

3.4

Training

Is specific GMP training provided? Is it tailored appropriately to the level of the role of the individual? Are general training needs identified? Are there training programs in place for all individuals? Are these programs appropriately tailored to the needs and role of the individual? Are there induction / training programs in place for newly recruited personnel? Are training programs regularly reviewed? Is the effectiveness of training evaluated Are there assessments on the knowledge individuals gain from training

3.5

Personal hygiene & Health

Do hygiene programs exist for all areas of the manufacturing plant Are they formally communicated to staff at all levels Are the procedures / SOPs readily available to operators. Do all personnel clearly understand the requirements of the program and the actions they need to undertake

As part of this program do personnel receive instruction on hand washing and why it is important to hygiene Do all staff (and visitors) wear appropriate clothing / protective garments to ensure cosmetic products are not contaminated - e.g. hair nets, overalls, gloves where appropriate Is there a clear policy prohibiting smoking, drinking and eating in production, storage and laboratory areas? Is it communicated to staff, enforced and clearly signed?

Are other unhygienic practices such as spitting etc prohibited in areas where the product may be affected? Are staff affected by illness or having open sores / lesions on exposed body surface instructed to report this to their line manager? After assessment and if there is a risk of contamination of product are they then prohibited from production areas? 3.6 Visitors & Untrained personnel Do procedures exist re visitors? ie they must be supervised at all times, what H&S information they require, protective clothing etc Are new personnel restricted from production areas until they have received induction / minimum specified training?

PZ Cussons Group GMP Audit v 1.1

Section

4.0

Premises
Back to '1 Index & Introduction'

ISO Ref

Area

Detail

NonCompliant Rating 1

Partially compliant Rating 2 Rating 3 Rating 4

Fully compliant Rating 5

Comments

4.2 4.3 4.4 4.5

Type of areas Space Flow Floors, walls, ceilings, windows

Are there separate or defined areas for storage, production, QC, staff facilities etc? Is the space allocated to these areas sufficient? Is there a defined and logical flow of materials / products through the production process Does the design / construction facilitate ease of cleaning and sanitisation where necessary? Ie smooth surfaces, rounded corners, chemically resistant surfaces where necessary Are they in good condition /state of good repair? Are windows non opening? Or if not then are they suitably screened to avoid ingress of birds, insects, contaminants?

n/a

No clear identification just A, B, C

Crancking floor, no borended corner

Only in injection area screened are available

4.6

Staff facilities washing / toilets / changing

Are the facilities provided adequate? Are facilities separate from but located close to production areas so as to enable easy access? where appropriate do changing rooms have designated clean side / dirty side Do lockers exist so that personnel can securely store their personal belongings / company issue overalls / PPE?

In injection area only

4.7

Lighting

Is lighting installed in all operations areas? Is the lighting adequate / meet any local legal standards? Are light bulbs protected / contained to ensure that if they break product is not contaminated? If not - then is the product protected from contamination in other ways e.g.. conveyor covers etc

n/a

4.8

Ventilation

Is ventilation sufficient for the intended production operations?

On going

Are suitable filters / meshes in place to prevent ingress of birds rodents, insects and external contamination? If not - then is the product protected from contamination in other ways e.g.. conveyor covers, sealed areas around filling machines etc 4.9 Pipework, ducts Are these installed in such a way so that drips / condensation, or dust falling from them, does not contaminate materials, products , surfaces and equipment? Are roof beams, pipework, ducts exposed so that dust could build up and contaminate the product? Is the design of these such that dust build-up is minimised? Wherever possible are they routed so as to avoid being directly overhead of production process? Are there regular cleaning schedules in place? Are exposed services away from walls to allow for ease of cleaning? e.g. supported by brackets and separated sufficiently for all round access for cleaning

Use Rentokil

N/A

Cleaning schedule only for building & Equipment

N/A

Or if the above measures are not practical / possible then are specific measures in place to protect materials and the product from contamination?

Drains

Are drains, covered, kept clean and do not allow back flow?

Generally is the production environment kept in a 4.10 Cleaning and sanitization of premises clean and tidy manner Are there scheduled cleaning and where necessary sanitisation regimes in place? Are these regimes customised to the specific needs of each area? Is the clear aim of these programs to protect the product Are sanitization regimes / agents validated? Are cleaning agents used effective? Is the construction and materials of floors, walls etc such that they can be easily cleaned? e.g. smooth walls & floors, joins between walls & floors are curved / radiused. 4.11 Maintenance Are the premises well maintained and in a good state of repair?

No need specific reginnes

No Rounded corners, Cracking Floor.

4.12 Pest Control

Are the premises designed and constructed to prevent / restrict access by birds, rodents, insects, pests and other vermin? Is there a pest control program in place?

Use Rentokil

PZ Cussons Group GMP Audit v 1.1

Section

5.0

Equipment
Back to '1 Index & Introduction'

ISO Ref

Area

Detail

NonCompliant Rating 1

Partially compliant Rating 2 Rating 3 Rating 4

Fully compliant Rating 5 In blow section

Comments

5.2

Equipment design

Is production equipment suitable design to prevent contamination of the product. e.g. lids on mixers etc? Are vessels holding tanks, product containers designed and constructed to avoid product contamination by dust or water? Are transfer hoses , pumps, other production accessories when not in use kept clean, dry and protected from contamination? Are the materials equipment is manufactured from compatible with the product and any cleaning / sanitization agents?

N/A

5.3

Installation

Is production equipment easy to clean and sanitize? e.g. completely drainable, no dead legs in attached pipework etc Is equipment suitably located to facilitate :Movement of materials Use of mobile equipment Use by personnel Ease of access for cleaning Ease of access for maintenance Are all major items of equipment clearly labelled? (production equipment and storage vessels). To ensure correct identification in SOPS etc

5.4

Calibration

Are all measuring instruments associated with production and assessment of quality (ie lab equipment) regularly checked and calibrated? Does each item of equipment have a calibration log / history? If calibration checks show unacceptable results / non operational - do procedures exist for equipment to be suitable flagged and removed replaced? If calibration is unacceptable - is there a procedure to check product quality of previous batches to ensure no negative effects on quality,

Equipment have calibration log

Are there fall back procedures if measuring equipment cannot be replaced immediately? 5.5 Cleaning and sanitization Do cleaning programs exist for all equipment Where required do sanitization regimes exist Are these regimes customised to the specific needs of each item of equipment? Is the clear aim of these programs to protect the product Is sanitization frequency clearly specified in the programs Are sanitization regimes / agents validated? 5.6 Maintenance Is all equipment regularly maintained? Maintenance procedures must not affect product quality Are defective items of equipment identified and removed from service Do planned maintenance procedures exist? Do equipment maintenance logs exist? 5.7 Consumables Are the consumables used for cleaning sanitising or maintenance of equipment checked to ensure that they do not adversely effect equipment or product?

Formulir inspection harian mesin produksi monitor / control temperatur dibuat th 2011 Shedule only for building there is chance the door stay open

5.8

Authorisation

Is access and control of production equipment limited to authorised and properly trained personnel only Are there fall back procedures if equipment that is faulty cannot be replaced immediately?

5.9

Back up systems

PZ Cussons Group GMP Audit v 1.1

Section

Raw materials and Packaging components

Back to '1 Index & Introduction'

ISO Ref

Area

Detail

NonCompliant Rating 1

Partially compliant Rating 2 Rating 3 Rating 4

Fully compliant Rating 5

Comments

6.2

Purchasing

Does a formal evaluation and selection process exist for material suppliers. Are technical clauses included within supply agreements? Items such as specification acceptance criteria, actions in case of defect / modification / rejection, transport conditions

N/A

6.3

Receipt

Are there procedures in place to check that purchasing order, delivery note and the materials that are actually delivered match Are the containers goods are shipped in visually inspected upon receipt to ensure they are sound / not been tampered with

6.4

Identification and status Are all containers / drums / sacks received correctly labelled with following details:Name of product on delivery document and packaging Suppliers name Suppliers batch reference code Are materials showing defects held / quarantined pending a decision Is their a dedicated area for this? Is this status of all materials clearly marked on the container - ie accepted, rejected, quarantined. Or if not? is there a clear system of another kind, in place that can offer the guarantee that materials conform to standard and are cleared to use

6.5

Release

Are their appropriate systems in place to ensure only released - approved materials are used ie SOP re use of green stickered approved mats or movement of only approved goods into designated areas Is approval / release of materials carried out by an appropriately competent and authorised person, ie QC supervisor / manager

If materials are accepted / approved solely on the basis of suppliers C of A - have all the following been considered / put in place:- Supplier audited - test requirements agreed - test methods agreed Has continuity of quality from the supplier been clearly demonstrated - ie a system of vendor assessment in place or as a minimum evidence that several shipments checked and all parameters found to be correct / within limits etc 6.6 Storage Are all materials stored in a correct and appropriate manner Is suppliers MSDS for material checked to ensure safe and appropriate storage is conducted When necessary are storage conditions monitored (ie cool rooms temperature checked regularly) Are all storage containers closed / sealed properly? Are Sacks, boxes trays of materials stored off the floor - it is acceptable for drums to be on the floor If materials are repacked for any reason - has all the appropriate labelling been applied? Are there procedures in place to ensure proper stock use / rotation ie FIFO (first if first out) Are there periodic stock inventories conducted? Are there systems to communicate and investigate stock discrepancies 6.7 Re -evaluation is shelf life data of materials and components known Is material shelf life monitored to ensure no out of time material is used Does a system for re-evaluation of materials exist 6.8 Water Quality Are there defined specifications for water quality Do the treatment systems in place deliver water to this specified quality consistently Are there systems in place to verify this by testing / monitoring can the water treatment systems be easily / periodically sanitised?

Not connducted

Evaluation in every 6 months, documented

N/A N/A N/A N/A 1 x in 6 months (stock opname) Install equipment or conduct temperature condition regularly

Is the water treatment equipment set up to avoid contamination / stagnation of water. materials of construction and treatment chemicals used must not adversely effect water quality

N/A N/A

PZ Cussons Group GMP Audit v 1.1

Section

7.0

Production
Back to '1 Index & Introduction'

ISO Ref

Area

Detail

NonCompliant Rating 1

Partially compliant Rating 2 Rating 3 Rating 4

Fully compliant Rating 5

Comments

7.1 7.2

Principle Manufacturing Operations

At each stage of manufacturing and packaging operations measures should be in place in order to ensure finished products meet the defined and specified characteristics

7.2.1 Documents

Is the relevant documentation available at each stage of the manufacturing operation and includes: - Equipment operation documents - formulation of product Is a batch card for product available which clearly states unique batch number, records lot numbers of materials used, quantities required and used, any batch adjustments made and final approval of batch Are detailed manufacturing instructions for the product available which should include: - material addition sequences, - temperature profiles - mixing times - mixing speeds - sampling points and instructions - cleaning instructions - Bulk transfer procedures Prior to manufacture is there a check to ensure operators have all relevant & correct documentation to enable production to commence Are all raw materials checked to ensure that they are correct and QC approved? Is equipment is checked for availability Is equipment is checked to ensure it is safe and in proper working order Is equipment, if necessary, cleaned and sanitised prior to use?

7.2.2 Start up checks

7.2.3 Batch number

Is a unique batch number allocated to each batch of bulk product made?

Is this properly recorded & linked to raw materials used and filling codes on packaging to ensure traceability is possible 7.2.4 Identification of in process operations Are all raw materials weighed accurately and into clean and appropriately labelled containers? Materials maybe weighed directly into mixing vessel providing controls are in place to avoid errors Are all items of equipment identifiable - ie mixers, pumps, key switches clearly labelled numbered? Are all bulk raw material storage tanks clearly identified? 7.2.5 In process QC controls Are appropriate in process QC control checks specified? Is frequency of checks specified? Are sampling points and sampling techniques specified Are procedures in place for reporting of results Are procedures / actions in place to deal with out of specification results Are out of specification results investigated, cause determined and necessary improvement actions put in place to prevent reoccurrence 7.2.6 Bulk product storage Are all containers of bulk finished product clearly labelled with product name, code, batch number Are storage conditions for the product clearly identified and displayed? (If required) Are maximum quantities of bulk product storage identified? Are there procedures in place to avoid excessive production? 7.2.7 Re stocking of Raw materials When quantities of raw materials are returned to storage are containers / products checked - to ensure they are not contaminated - to ensure they are correctly labelled - that containers are properly sealed closed - that correct quantity of remaining material is shown on outside of container 7.3 Packaging operations Packaging operation should be carried out to specified and detailed documentation / specifications Is the relevant documentation available at each stage of the packaging operation and does it include: - detailed instructions on pkg equipment set up - filling equipment cleaning and sanitisation procedures

7.3.1 Documents

- lists and standards of materials for the intended finished product - check lists to ensure all pkg components are available - details on how the product primary container should be coded 7.3.2 Start up checks - details on how product should be palletised Prior to filling is there a check to ensure that the area has been cleared of all pkg components from previous operations Prior to manufacture is there a check to ensure operators have all relevant & correct documentation to enable filling to commence Do physical samples or photographs of the intended product exist to act as standards for reference by line operators? Are there checks to ensure that pkg components are available & correct quantity. Are there checks to ensure labels are correct and bar codes are readable? Are there checks to ensure that the correct pkg equipment is available and in good operation. Are there checks to ensure filling equipment is clean and where necessary sanitised? Has the coding to be applied to the product been issued and checked for accuracy? 7.3.3 Batch number Is a unique batch number / code applied to the primary pkg to enable identification of: - date product filled (time optional) - which shift - which packaging line Is this coding recorded and linked to bulk product batch code to ensure traceability is possible? 7.3.5 On line control equipment 7.3.6 In process control Is equipment such as weight checkers recorders checked regularly to a defined schedule? Are in process control checks such as product weight, cap tightness, label positioning etc in place? Is there a defined schedule for these tests? Are agreed acceptance criteria / limits specified Are procedures in place to deal with results that are out of specification? When quantities of packaging materials are returned 7.3.7 Re stocking of packaging components to storage are containers checked - to ensure they are correctly labelled

- that containers are properly sealed closed - that correct quantity of remaining components is shown on outside of container 7.3.8 Identification and handling of work in process Filling and labelling is normally a continuous process. When this is not the case then procedures must be in place to ensure product is not mixed up or mislabelling occurs Are there clear procedures in place that specify how stocks of unlabelled but filled product is identified Where they should be stored

PZ Cussons Group GMP Audit v 1.1

Section

8.0

Finished Products
Back to '1 Index & Introduction'

ISO Ref

Area

Detail

NonCompliant Rating 1

Partially compliant Rating 2 Rating 3 Rating 4

Fully compliant Rating 5

Comments

8.1

Principles

Finished products must meet the defined acceptance criteria Storage, shipment and returns should be managed in a manner to maintain their quality

8.2

Release

Do acceptance release criteria exist for all finished products Are appropriate checks conducted on finished products to ensure they meet all defined specifications? Do agreed and validated test methods exist for all checks required? Are operators / QC personnel suitable trained in these methods? Are methods readily available to personnel in production / QC areas so they can check method details if required Is product release carried out by authorised personnel from the quality function?

8.3

Storage

Are products stored in an appropriate manner? Ie organised / tidy / safe Do SOPs exist which specify how products should be palletised and stored - ie pallet configurations, maximum stacking limits, shrink wrapping of pallets etc Are there defined and segregated areas for released, quarantined or rejected finished products? Are there defined time limits for storage of products? Is there a defined process to periodically monitor the physical quality of finished products? Are pallets of finished products properly identified and labelled? Ie with name / identifying code, batch number etc

Are there systems in place to ensure there is proper stock rotation / FIFO? Are periodic checks conducted on inventory? 8.4 Shipment Do SOPs exist for checking cleanliness and integrity of transportation / containers Are there defined processes to ensure products are properly transferred into containers or onto lorries to ensure quality is maintained - ie stacking configurations & limits, use of layer boards, use of protective materials re possible condensation etc

8.5

Returns

Are product returns stored in a defined and segregated area? Are they clearly labelled as returns? Do procedures exist re what checks and what criteria are applied to determine the status of returned products ie acceptable product which can be reshipped / sold or product that requires rework or product that must be scrapped? Is returned product release carried out by authorised personnel from the quality function? Are appropriate records kept to ensure return product released again for sale can be properly identified (ie distinguished separately from original production)

PZ Cussons Group GMP Audit v 1.1

Section

9.0

Quality control laboratory

Back to '1 Index & Introduction'

ISO Ref

Area

Detail

NonCompliant Rating 1

Partially compliant Rating 2 Rating 3 Rating 4

Fully compliant Rating 5

Comments

9.1

Principles

1 The principles described for personnel, premises, equipment, and documentation also apply to Quality control laboratory 2 The QC lab is responsible for ensuring the necessary and relevant controls are carried out for sampling and testing so that materials are released for use and products are released for shipment, only if their quality fulfils the required acceptance criteria 3 The quality control manager must not report directly to operational level production management

9.2

Test methods

Do documented test methods for all relevant quality checks / analysis exist? Are they subject to proper document control procedures? Ie issue date, issued by, authorised by etc Are they based on recognised international stds or from professional bodies ie Iso ASTM British or other country stds

Ada test methode untuk eqiupment : WI Cappng test (WI-QA-09), WI Uji tingkat kebocoran (WI-QA-07), WI Wall thickness (WI-QA-07)

N/A

9.3

Acceptance criteria

Are acceptance criteria / QC limits clearly detailed in raw material, packaging or finished product specifications Have these limits been reviewed and agreed to by all relevant parties? Ie Quality, production, marketing where appropriate

The limit agree by quality and Marketing

9.4

Results

Are procedures in place to ensure that QC test results are reviewed and acted upon in a timely manner? Are the levels of authority for personnel in QC to provide decisions clear?

9.5

Out of specification results

Are out of specification results reviewed separately by authorised personnel? Are they investigated properly and reported on? Ie root cause analysis, costs of incident, improvement / follow up actions recommended etc If retesting is requested, has there been a proper assessment to justify this action?

9.6

Reagents etc

Are all reagents and chemical solutions, labelled and identified correctly ie with name, strength concentration, initial date, expiry date, name or person who prepared material, any special storage conditions required. Are all reference standards labelled and identified correctly ie with name, initial date, expiry date, name or person who prepared material, any special storage conditions required. Are reference stds also approved by relevant marketing function

N/A

Training MIL STD

9.7

Sampling

Is sampling performed by suitable trained personnel Do SOPs for sampling exist that specify the method , equipment amounts to be taken, sampling point, how sample is to be identified and frequency of sampling?

Are samples properly coded / identified and details properly recorded? Ie with name or code, batch number, time & date, where taken (sampling point / container tank, vessel etc) 9.8 Retained Samples Are retained samples of materials and intermediates (where appropriate) kept? Is the sample size retained appropriate for any subsequent re analysis which maybe required (due to issues or regulations) Are retained samples of finished products taken and kept in their primary packaging? Are these samples retained for specific periods either to company guidelines or to legal requirements? Are all samples stored in an secure and appropriate manner

PZ Cussons Group GMP Audit v 1.1

Section

10.0

Treatment of product that is out of specification

back to '1 Index & Introduction'

ISO Ref

Area

Detail

NonCompliant Rating 1

Partially compliant Rating 2 Rating 3 Rating 4

Fully compliant Rating 5

Comments

10.1 Rejected products

Are procedures in place to deal with out of specification items These can be raw materials, packaging components, intermediates, bulk batches or finished products Are there appropriately qualified & authorised personnel assigned to assess and deal with the non conformance process Do non conformance procedures include input / assessments of product from technical, legal, commercial, marketing etc depts (where appropriate) prior to end decision on release, rework, scrapping of product? Is authorisation to proceed given on basis of Quality dept recommendation and final sign off by senior management

N/A

10.2 reprocessed finished products 10.2 reprocessed bulk products

For finished product returns see section 8.5

Do procedures exist re what checks and what criteria are applied to determine the status of the bulk product? ie criteria decision making process that decides if product can be reprocessed or needs to be scrapped Is bulk product that requires reprocessing stored in a defined and labelled container / vessel /storage tank Are there measures in place to ensure it cannot be used / filled off until decision has been made Is reprocessed bulk product release (to specified acceptance criteria) carried out by authorised personnel from the quality function? Are appropriate records kept to ensure reprocessed bulk product can be properly identified (ie distinguished separately from original production)

N/A

N/A

N/A

N/A

N/A

PZ Cussons Group GMP Audit v 1.1

Section

11.0

Wastes
Back to '1 Index & Introduction'

ISO Ref

Area

Detail

NonCompliant Rating 1

Partially compliant Rating 2 Rating 3 Rating 4

Fully compliant Rating 5

Comments

11.1 Principal 11.2 Types of waste

Efforts should be made to minimise waste generation in the first place. Any waste generated should be disposed of in a timely, efficient, safe and legal manner. Are wastes generated by the operation reviewed / studied to understand if they have any effect on product quality. or functionality of laboratory analysis) Does the production and subsequent storage, disposal of waste have any effect of factory / laboratory operations Are any wastes generated disposed off in a timely, efficient and legal manner

N/A

11.3 Flow

11.4 Containers

Are containers of waste properly identified / labelled with the contents and any appropriate health & safety information (or other information that may be legally required) Are waste containers properly sealed and suitable for storage of the wastes they contain?

N/A

11.5 Destruction of waste

If waste is disposed of on site, are adequate processes in place to ensure it is conducted properly? Ie safely, no harmful effects to environment, legally etc

If waste is disposed of externally and via a / contractor has the third party and its processes / modes of disposal, been audited Is all waste disposed of according to legal requirements?

N/A

N/A