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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 FA. !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 folloing "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 esponsiilities 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 FA 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;
*. "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 aareness process is documented in our raining and Aareness 'rocedure *O' 8 A 8 ;91 raining and Aareness6.
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B Premises 1. Grounds
Our company is located in an area aay from ma=or pollutants. It is constructed and maintained to protect it from contaminants. %ood house>eeping is applied according to our "aintenance of 'remises 'rocedure *O' 8 2 8 191 %eneral "aintenance of 'lant and 'remises6. his is the same procedure as for preventive maintenance( see 5.1 in AO 153 for %eneral "aintenance6 !ist other measure you are ta>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
:
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 @$planatory leaflet of the e4uipment and machines *O' 8 # 8 1916.
'ossibly, this can also be called -!ist of e4uipment/
It is the company0s policy to minimi7e all glass parts at e4uipment. If e4uipment contains glass part it is indicated in the %lass +egister *O' 8 # 8 19;6.
All e4uipment is installed ith ade4uate space from each other in order to minimi7e cross:contamination as indicated in the company?s "aster 'lan iagram see *O' 8 2 8 ;91 "aster plan 6
All e4uipment ill be cleaned and maintained according to the company0s "aintenance, #leaning and *anitation 'rogram *O' 8 8 591 "aintenance, #leaning and *anitation 'rogram6.
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0. Sanitation and &giene 1. Personnel
1.1. isease #ontrol
It is one of the company0s policies that any personnel ho is shon to have, or appears to have, an illness, open lesion, including boils, sores, or infected ounds, or any other possible source of microbial contamination is e$cluded until the condition is corrected. 'rior to or> every nely hired employee ill undergo a medical chec>:up to e$amine hisher health condition. +egular chec>:ups ill be held according to our isease #ontrol 'rocedures *O' 8 8 1116 &ealth certificates of each employee are re4uired by the "anagement . #omment his can be stated in the *O'. efine here you ill >eep these >inds of records. raining is a good a ay to sho to the inspector that employee have been made aare of isease #ontrol and 'ersonal &ygiene.
1.; &ygienic 'ractices
It is the company0s policy that all personnel ho handle food or are involved in the food processing are obliged to act according to hygienic practices hile on duty to the e$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 handashing procedures, escribe ho you ould supervise that everybody follos 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 aareness process is documented in our raining and Aareness 'rocedure *O' 8 A 8 ;91 raining and Aareness6.
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;
2. Sanitar acilities
he company provides all necessary sanitary facilities as follos
!ist up hat sanitary facilities you provide, e.g. Water supply 8 you might use potable ater for production and non: potable ater for other purposes. escribe it here( @ffluent and Waste diposal #hanging facilities oilets
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&andashing Facilities isinfection facilities only if you consider them necessary6 Facilities for storage of aste and inedible material @ating facilities Others
All these sanitary facilities are indicated in the company0s "aster 'lan iagram see *O' 8 2 8 ;91 "aster plan6. 5. Maintenance and Sanitation
5.1 %eneral "aintenance, #leaning and *anitation 'rogram
he establishments and e4uipment of the company are regularly maintained, cleaned and saniti7ed according to the company0s "aintenance, #leaning and *anitation 'rogram *O' 8 8 511 "aintenance, #leaning and *anitation 'rogram6. For the company good maintenance is a musta prere4uisite to ensure and facilitate proper sanitation procedures and to prevent possible contamination from metal shards, fla>ing plasters, debris and chemicals.
@mployees responsible for maintenance, cleaning and sanitation are appropriately trained on relevant fields regarding food safety according to the company0s raining and Aareness 'rocedure *O' 8 A 8 ;91 raining and Aareness6.
5.; 'est #ontrol
All >ind of animals are strictly e$cluded and prevented from all food processing activities according to company0s policies.
"easures such as e.g. ire mesh screens or electrocution traps ta>en by the company in order to control pest and vermin ithin the premises. Page 1$ 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 glassare or glass parts are used, they are registered in the company0s %lass register *O' 8 # 8 19; %lass register6.
2rose 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 revieed 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 0istriution 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 ithdran from the production as described in *O' 8 @ 8 191 Flo iagram and 'rocess escription
7. Su8/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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