Gowning Procedure

1.0              OBJECTIVE

1.1              To outline the procedure for personal cleanliness for entry into high risk zones.

2.0              PROCEDURE

3.1              Enter into the change room.

3.2        Remove he accessories like mobile phones, wrist watches, rings, wrist bands, ornaments or jewellery.

3.3            Before entering, personnel shall either cover their street shoes with disposable covers or wear footwear that are earmarked for this purpose.

3.4              Move to the other side of the crossover bench.

3.5              Wash hands thoroughly.

3.6              Wear head gear to cover head.

3.7              Wear the mask and cover the beard.

3.8             Wear the gown. 

3.9              Take one or two drop of hand sanitizer on palm and rub it to evaporate it.

3.10          Enter the high risk zone.

3.11     Person shall remove their gowns and keep them in the change room before going outside the area.

3.12       Remove all the gowns whenever going out of the high risk zone even for a short period.

3.13          Follow entire procedure all over again whenever you re-enter the high risk zone.

3.14          Use neck chain for the spectacles or safety eye glasses.  

3.15          All the gowns shall be collected in basket and sent to the laundry at the end of the day.

4.0              ABBREVIATIONS

4.1              NIL

5.0              ANNEXURES

5.1              NIL

6.0              REFERENCE

6.1              NIL

            Detail gowning procedure and board are available if users/readers require the same. If there are any query/questions or suggestions related to the article, readers are requested to mail their query at anshuyadav.icgian@gmail.com. 

AUTHOR :ANSHU YADAV

anshuyadav.icgian@gmail.com

HAND WASHING TECHNIQUE

Hand washing is an important step which is to be followed before entering into the manufacturing and processing area of any food and Pharmaceutical company. Hand washing facility is generally inspected during any regulatory inspection or customer audit.

In many of the manufacturing unit the supervisors/workers or operators are unable to understand the procedure in english, therefore it shall be written in their local language.

Below is the procedure given for hand washing. Target audience are supervisors/workers and operators of the manufacturing unit in food and pharma companies

      1.     Wet the hands with water.  अपने  हाथो  को  पानी  से  गीला करें 

2.      Take some liquid soap on the palm.   तरल साबुन को अपनी हथेली पर ले 

3. Make lather of the soap by rubbing palm together. दोनों हथेलियों को आपस में रगड़ कर झाग बनायें 

4.     Rub your hands as below step wise:  अपने हाथो को इस प्रकार रगड़िए

             4.1       Both the palms together / दोनों हथेलिओं को आपस में रगड़े

             4.2    Rub back of each hand with the other palm  /  एक हथेली से दुसरे हाथ के ऊपर के हिस्से को  रगड़िए 

4.3        Interlace finger and rub together as below.  / दोनों हाथों की उंगलिओं को नीचे बनी  आकृति  की तरह मिला कर आपस में रगड़ें  

4.4        Curl the back of the finger into one palm then the other.  / एक हाथ की उंगलिओं को मोड़ कर दुसरे हाथ की हथेली को रगड़ें

4.5     Hold thumb and rotate with both hands / एक हाथ के अंगूठे को दुसरे हाथ से पकड़ें और घुमाए

5.     Wash the hands with plenty of water. / फिर पानी से अपनी हाथ को अच्छी तरह से धोएं

6.     Dry the hand with the help of Dryer./ ड्रायर की मदद से अपनी हाथों को सुखाएं 

7.     The above process will be done every time when the workers are entering in the process area./

ऊपर दिया हुआ तरीका एम्प्लोयी को जब भी वह प्रोसेस एरिया में जाये फॉलो करना है I

As per 21 CFR 110.37 (e)

Hand washing facilities shall be adequate and convenient and be furnished with running water at a suitable temperature.

Compliance may be accomplished by providing ;

a) Hand washing facilities and where appropriate hand sanitizing facilities at each location in the plant where good sanitary practices require employees to wash and/or sanitize their hand.

b) effective hand cleaning and sanitizing preparations.

c) Sanitary towel service or suitable drying devices.

d) Devices or fixtures, such as water control valves, so designed and constructed to protect against re-contamination of clean, sanitized hands.

e) Readily understandable signs directing employees handling unprotected food, unprotected food packaging materials, of food contact surfaces to wash and where appropriate, sanitize their hands before they start work, after each absence from post of duty, and when their hands may have become soiled or contaminated. These signs may be posted in the processing room(s) and in all other areas where employees may handle such food, material, surfaces. 

f) Refuse receptacles that are constructed and maintained in a manner that protects against contamination of food.

g) Rubbish and offal disposal. Rubbish and any offal shall be so conveyed, stored and disposed of as to minimize the development of odor, minimize the protection for the waste becoming an attractant and harborage or breeding place for pests, and protect against contamination of food, food contact surfaces, water supply and ground surfaces.

If there are any query/question or suggestions related to the article readers are requested to mail there query at anshuyadav.icgian@gmail.com.

AUTHOR : ANSHU YADAV

anshuyadav.icgian@gmail.com.

Analysis of warning letter issued by US-FDA

An inspection took place in one of the food manufacturing facility by investigator of US-FDA. During that inspection significant violations were observed against 21 CFR part 110 regulation which causes the food product that the company manufactures to be adulterated within the meaning of Section 402 (a) (4) of Federal Food. Drug, and cosmetic act [ 21 U.S.C. 342 (a) (4)].

21 CFR part 110 here refers to current good manufacturing practices in manufacturing, packing or holding human food. 

and Section 402 (a) (4) of Federal Food. Drug, and cosmetic act [ 21 U.S.C. 342 (a) (4) says that
If the product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health;

Below are some of the observation which each food and pharma company shall review at theier manufacturing premises and understand how it is linked with code of federal regulations.

Observation 1- The firm failed to take effective measures so that the pest could be excluded from the processing area and to protect against the contamination of food on the premises by pests.These requirements are mentioned in 21 CFR 110.35(c) and 21 CFR 110.20 (b)(7)

21 CFR 110.35(c)
Where 
Title 21-Food and Drugs
CFR refers to Code of federal regulation
PART 110- CURRENT GOOD MANUFACTURING IN MANUFACTURING, PACKING OR HOLDING HUMAN FOOD.
Sec.110.35 Sanitary Operations

21 CFR 110.35(c) Pest Control : No pests shall be allowed in any area of the food plant, Guard or guide dogs may be allowed in some areas of a plant if the presence of the dogs is unlikely to result in contamination of food, food contact surfaces, or food packaging materials. Effective measures shall be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests. The use of insecticide or rodenticide is permitted only under precautions and restrictions that will protect against the contamination of food, food contact surfaces, and food packaging materials.

21 CFR 110.20 (b)(7) Provide, where necessary, adequate screening or other protection against pests.

Observation 2-Failure to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food and food contact surfaces, as per 21 CFR 110.35(a) and 21 CFR 110.3(o)

21 CFR 110.35 (a) GENERAL MAINTENANCE

Building, fixtures and other physical facilities of the plant shall be maintained in a sanitary condition and shall be kept in repair sufficient to prevent food from becoming adulterated. Cleaning and sanitizing of utensils and equipment shall be conducted in a manner that protects against contamination of food, food contact surfaces, or food-packaging material.

21 CFR 110.3(o)
Sanitize means to adequately treat food contact surfaces by a process that is effective in destroying vegetative cells of microorganism of public health significance, and in substantially reducing numbers of other undesirable microorganism, but without adversely affecting the product or its safety for the consumer.

Observation 3 

Lack of effective hand cleaning and sanitizing preparations, as per 21 CFR 110.37(e).

As per 21 CFR 110.37 (e) Hand washing facilities: Hand washing facilities shall be adequately and convenient and be furnished with running water at a suitable temperature. Compliance with this requirement may be accomplished by providing:

1) Hand washing and, where appropriate, hand sanitizing facilities at each location in the plant where good sanitary practices require employees to wash and/or sanitize their hands.

2) Effective hand cleaning and sanitizing preparations

3) Sanitary towel services or suitable drying devices.

4) Device or fixtures, such as water control valves, so designed and constructed to protect against recontamination of clean, sanitized hands.

5) Readily understandable sign directing employees handling unprotected food, unprotected food-packaging materials, of food contact surfaces to wash and, where appropriate, sanitize their hands before they start work, after each absence from post of duty, and when their hands may become soiled or contaminated. These sign may be posted in the processing room(s) and in all other areas where employees may handle such food, material, or surfaces.

6) Refuse receptacles that are constructed and maintained in a manner that protects against contamination of foods.

7) Rubbish and offal disposal  shall be so conveyed, stored and disposed of as to minimize the development of odor, minimise the potential for the waste becoming an attractant and harborage or breeding place for pests, and protecting against contamination of food, food contact surfaces, water supplies and ground surfaces.

If there are any query, question related to the article, readers are requested to mail their query at anshuyadav.icgian@gmail.com.

Author : ANSHU YADAV

anshuyadav.icgian@gmail.com.

DEVIATIONS

Deviation can be defined as departure from an approved instruction or established standard.

Such deviation may adversely affect the desired quality of the pharmaceutical product. Such deviation must be avoided, but if required than must be justified and explained if there is any quality impact on the pharmaceutical product. The noted deviation must be properly authorised and recorded. The deviation are defined in ICH Q7 as well as M schedule.

ICH Q7 states that

1. Any  deviation from the established procedure should be documented and explained. Critical deviation should be investigated and the investigation and its conclusion should be documented.
2. It is the responsibility of the quality units to ensure that critical deviations are reported, evaluated, completed and signed.
3. In product quality review, a review of all critical deviation or non conformance and related investigation must be recorded.
4. Deviation from the approved standards of calibration on critical instruments should be investigated if stored separately.
5. Written procedure should be established and followed for investigating critical deviations or the failure of a batch of intermediate or API to meet the specification. the investigation should extend to other batches that may have been associated with the specific failure or deviation.
6. All deviation reports should be reviewed as part of the batch record review before the batch is released.
7. Deviation in yield associated with critical process steps should be investigated to determine their impact or potential impact on the resulting quality of affected batches.
8. A validation report that cross reference the validation protocol should be prepared, summarising the result obtained, commenting on any deviation observed and drawing the appropriate conclusion including recommending changes to correct deficiency.

M schedule also talks about deviation but not in so much of details. As per M schedule :

1.  Comments or explanation for significant yield limit shall be given.
2.  There shall be notes on special problems including details with signed authorisation for any    deviation from the master formula. 

If there are any query, question related to the articleor requirement of deviation formats , readers are requested to mail there query at anshuyadav.icgian@gmail.com.