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GMP Manual (Based on cGMP requirements according to AO 153)

Our Company Street Address City, State Country Postal Code

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Scope Write a paragraph here to clearly identify the scope of your system. Include the products, product categories, processes and production sites that are included in your system.

Normative e!erences  Administrative Order 153 issued by FA. !ist other references used in the development of your manual

"erms and de!initions !ist terms that you use that should be defined. "aybe #ode$ Alimentarius on %ood &ygiene 'ractices(

#nstructions !or t$is Manual% )se the AO 153 as a reference as you modify this manual to apply to your *ystem. +eplace the ords -he #ompany/ and -he #ompany0s/ ith your company name. Any red te$t is instructional and should be deleted from the manual. he headers are in the folloing "icrosoft Word *tyles associated ith this O#ument

Section &eading ( !ollo'ed  t$e ta to ring line to t$e page edge) &eading * 2ody e$t Heading 3 2ody e$t

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A GMP Organi+ation 1 Organi+ation, -uali!ication, and esponsiilities he company0s uality *ystem has been designed to ensure the provision of safe, 4uality products to our customers.

he *ystem has been built and implemented based upon the principles and re4uirements of the current Good Manufacturing Practices  %"'6 issued by the 'hilippine FA in the AO 153. he company has established different departments to ensure the strict implementation of these %"' guidelines as indicated in the organi7ational chart see *O' 8 A 8 191 Organi7ational #hart6. he responsibilities of the different managerial and supervisory staff are clearly defined see *O'8 A:19; ing to >eep good your premises ell maintained(

*. Plant /onstruction and 0esign

'lant, building and structures are designed in a ay to comply ith the re4uirement of the c%"' and to minimi7e the ris> of cross contamination that ill affect the safety of the product. he #ompany?s "aster 'lan iagram see *O' 8 2 8 ;91 "aster plan 6 provides an overvie of relevant Food *afety issues

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2uilding outline ith production areas, service areas and surroundings.

:

'rocess flo, or>er0s flo, ra material flo.

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Waste collection area, aste ater drain off 

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efinition of areas 8 in terms of hygiene 7ones and functions

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rin>ing ater supply

!ist other relevant details(

"inimum design and constructions re4uirements of plant facilities are fulfilled and our #ompany has used materials hich are suitable for food processing Page  of 18

see *O' 8 2 8 ;9; @$planatory leaflet of materials used and techni4ues of constructions employed6.

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/. quipment

 All e4uipment used for food production is designed and constructed in a ay as to minimi7e cross:contamination during production and to facilitate easy cleaning.  All material used for the construction of e4uipment is resistant to corrosion and non:to$ic. etails about the e4uipment used for production can be seen in the company0s @$planatory leaflet of the e4uipment and machines *O' 8 # 8 1916.

'ossibly, this can also be called -!ist of e4uipment/

It is the company0s policy to minimi7e all glass parts at e4uipment. If e4uipment contains glass part it is indicated in the %lass +egister *O' 8 # 8 19;6.

 All e4uipment is installed ith ade4uate space from each other in order to minimi7e cross:contamination as indicated in the company?s "aster 'lan iagram see *O' 8 2 8 ;91 "aster plan 6

 All e4uipment ill be cleaned and maintained according to the company0s "aintenance, #leaning and *anitation 'rogram *O' 8  8 591 "aintenance, #leaning and *anitation 'rogram6.

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0. Sanitation and &giene 1. Personnel

1.1. isease #ontrol

It is one of the company0s policies that any personnel ho is shon to have, or appears to have, an illness, open lesion, including boils, sores, or  infected ounds, or any other possible source of microbial contamination is e$cluded until the condition is corrected. 'rior to or> every nely hired employee ill undergo a medical chec>:up to e$amine hisher health condition. +egular chec>:ups ill be held according to our isease #ontrol 'rocedures *O' 8  8 1116 &ealth certificates of each employee are re4uired by the "anagement . #omment his can be stated in the *O'. efine here you ill >eep these >inds of records. raining is a good a ay to sho to the inspector that employee have been made aare of isease #ontrol and 'ersonal &ygiene.

1.; &ygienic 'ractices

It is the company0s policy that all personnel ho handle food or are involved in the food processing are obliged to act according to hygienic practices hile on duty to the e$tent necessary to protect against contamination of food.

 Ade4uate protective clothing ill be provided by the company.  All employees must adhere to the company0s policy in regard to hygienic practices. *O' 8  8 1;16. 'lease define hat >ind of procedures, records, etc you ant to have to sho to the inspector that you comply ith this clause

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'ointers *O' 8  8 1;1 &ygienic 'ractices 'olicy escribe hat protective clothing you ant your employees to ear, escribe handashing procedures, escribe ho you ould supervise that everybody follos the policy, escribe training, etcB,6 *. ducation and "raining

 All our staff undergoes continuous training, hich is regularly instituted, updated and validated, in %"' and Food *afety and is 4ualified for their  =ob duties. he training and aareness process is documented in our raining and Aareness 'rocedure *O' 8 A 8 ;91 raining and  Aareness6.

3. Supervision

 Authority and responsibilities are clearly assigned according to the company0s organi7ational chart to ensure compliance see O# 8 A 8 191 Organi7ational #hart6. he responsibilities of the different managerial and supervisory staff are clearly defined see *O'8 A:19; en by the company in order to control pest and vermin ithin the premises. Page 1$ of 18

 Additionally, the company contracts an e$ternal pest control company to operate an effective pest control program in all relevant areas of the company. *O' 8  8 5;1 'est #ontrol 'rogram6.

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. Production and Process /ontrols 1. Production Processes and /ontrols

he process flo is designed in a ay that all operations are conducted in accordance to sanitation principles and guarantee Food safety of the products.  A flo diagram is prepared and used as a basis for evaluating food safety ha7ards. he accuracy of the diagrams is verified through on:site chec>ing by 4ualified personnel. maybe also by the Food *afety eam if already founded 8 better(6. he flo diagram identifies the e$isting control measures, process parameters or procedures that influence food safety as ell as relevant e$ternal re4uirements *O' 8 @ 8 191 Flo iagram and 'rocess escription6. #onsider Cou might need more than one flo diagram to describe your processes(6

1.1 +a "aterials and other Ingredients

+a materials and other ingredients are inspected and controlled at the receiving and must apply to the company0s specifications *O' 8 @ 8 1.1.1 +a "aterial *pecification !ist6.

Cou might also re4uest the supplier for a letter of guarantee or certificate of analysis 8 this is an important ocument( #onsider this and specify( e.g. *uppliers are re4uested to submit a certificate of analysis for their product, see O# 1.1.; !ist of #OAs6

hey are properly stored to protect against contamination and to minimi7e deterioration see *O' 8 @ 8 191 Flo iagram and 'rocess escription6.

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1.; "anufacturing Operations

 All manufacturing operations necessary for the sanitary handling and maintenance of e4uipment and utensils are established. @4uipment, utensils and finished food containers are maintained in a sanitary condition according to the company0s "aintenance, #leaning and *anitation 'rogram *O' 8  8 511 "aintenance, #leaning and *anitation 'rogram6.

'hysical factors important for the consistency, 4uality and safety of the product are monitored see *O' 8 @ 8 191 Flo iagram and 'rocess escription6. %lass ithin the production is generally avoided. Where glassare or glass parts are used, they are registered in the company0s %lass register *O' 8 # 8 19; %lass register6.

2rose through clause 1.; "anufacturing operations and decide hich clauses are relevant for your company and describe ho you ould deal ith them, maybe in the process flo diagram( Indicate relevant ocuments(

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. -ualit /ontrol 1. -ualit Management he company0s 4uality control system is established. It involves sampling, inspecting of starting materials, in process, intermediate, bul> and finished product. ecide hat >ind of testing you ant to establish in your company. #hec> ith the 2FA re4uirements !ist of laboratory analysis for food microbiology and food chemistry6. #onsider 4uality as ell as food safety issues( #onsider +evie of batch ocumentation *ample retention program *tability studies if necessary6 'roduct complaints 'roduct recalls *pecifications of materials and products

*. "esting o! eprocessed Products and "esting o! eturned Goods

If deviations at critical control points or control point occur, the company ill decide hat actions ill be ta>en to guarantee Food *afety of the product *O' 8 F 8 ;91 eviations 'rocedure6. In case of reprocessing the finished product ill be tested again.  Additional testing of finished product ill be performed if considered necessary. +eturned goods are stored separately and tested if necessary. Any returned products that do not comply ith the original specification ill be re=ected and disposed as described in the eviations 'rocedure *O' 8 F  8 ;91 eviations 'rocedure6.

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Page 1 of 18

G. 0ocumentation he company0s %"':system is ocumented in this %"' "anual, 'rocedures, Wor> Instructions and +ecords. he company0s ocument control process ensures that all %"' ocuments are controlled. All proposed changes are revieed for their effect on food safety, 4uality and consistency and approved before implementation. his process is ocumented in our ocument #ontrol 'rocedure *O' 8 % 8 191 #ontrol of ocuments6. he procedure defines ocument control including ocument approval, revie, update and re:approval of ocuments, identification of changes and current revision, availability of current ocuments at point of use, legibility and identification of ocuments, control of ocuments of e$ternal origin and prevention of unintended use of obsolete ocuments. he company controls records according to our uality +ecords 'rocedure. *O' 8 % 8 19; #ontrol of +ecords6 his process addresses the steps re4uired to establish and maintain our records to demonstrate the company0s conformance to %"' re4uirements as ell as regulatory re4uirements. he procedure defines identification, storage, protection, retrieval, retention time, and disposition methods.

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&. -ualit Audits Internal audits are conducted to verify the effectiveness of the %"' system. Audits determine hether the system conforms to the re4uirements  An Internal Audit procedure describes the audit process, responsibilities and authorities *O' 8 & 8 191 Internal Audit 'rocedure6 he procedure defines the criteria, scope, fre4uency and methods used for the audit process. A report ill be made at the completion of each 4uality audit.

#. 4are$ousing and 0istriution he company has established procedures for sanitary handling of food on storage and distribution in order to protect the product against physical, chemical and microbial contamination as ell as against deterioration of the food and the container. he company0s Warehousing and istributions 'rocedure describes the sanitary handling of the product considering *O' 8 I 8 191 Warehousing and istribution 'rocedure6 :

*toc> rotation FIFO, F@FO6

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*eparate storage of goods from chemicals, potentially contaminated incoming materials, defective stoc>, mar>et returns or complaint goods

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*ecurity and tidiness of storage facilities

. Product ecall  All 4uality or safety:related complaints, hether received orally of in riting, are recorded and investigated by the company.

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 After evaluation corrective actions are ta>en according to the company0s #ustomer #omplaints &andling 'rocedure *O' 8 < 8 191 #ustomer #omplaints &andling 'rocedure6.  Actions are ta>en to prevent any nonconforming product from entering the food chain unless it has been determined that the food safety ha7ard has been reduced to stated acceptable levels or ill be before entering the food chain or that the product meets acceptable levels despite of the nonconformity.  All lots of product that may have been affected by non:conformity are held under control until they have been evaluated. If any product has left control of he #ompany a recall is initiated according to 'roduct +ecall 'rocedure *O' 8 < 8 19; 'roduct +ecall 'rocedure6.

6. etention o! Samples

+etention *amples are ithdran from the production as described in *O' 8 @ 8 191 Flo iagram and 'rocess escription

7. Su8/ontracting o! Manu!acture he conditions of contract manufacturing if any6 ill be defined, agreed and controlled. +elevant ocuments are >ept.

'ointer his clause might be not relevant for your company but maybe you have a contracted pest control company.

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